(277 days)
Not Found
No
The document describes a physical therapy table with manual and electrical movements, but there is no mention of AI or ML capabilities.
Yes.
The device is specifically described as a "Multi-function physical therapy table" intended for "medical purposes" to provide "patients with powered flexion, and muscle relaxation therapy," which are therapeutic functions.
No
Explanation: The device description states that the AGILIS is a "Multi-function physical therapy table" intended to provide therapies like "powered distraction, powered flexion, and muscle relaxation therapy." It is used for medical purposes, but its function is therapeutic, not diagnostic.
No
The device description clearly outlines a physical therapy table with various mechanical and electrical components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy." This describes a physical therapy device used for treatment, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical therapy table with various manual and electrical operating systems for movement and manipulation. This aligns with a physical therapy device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other components typically associated with in vitro diagnostics.
Therefore, the AGILIS Multi-function physical therapy table is a medical device used for physical therapy treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
AGILIS is a multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies
Product codes (comma separated list FDA assigned to the subject device)
JFB
Device Description
The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.
Manual operation systems:
-. Headpiece.
-. Extension of feet.
Drops. .
Dorso - lumbar release/breakaway
Lateral Flexion. ●
Electrical operating systems:
-. Horizontal elevation.
-. Flexion of the lower limb sector.
Extension or linear movement of the lower limb sector (distraction/traction).
Physiotherapy table models:
AGILIS "PLUS" multifunction physiotherapy table, is the most complete model in the line of physiotherapy tables and has the following features:
- Lifting system with 24Vdc electric motor/actuator. .
- Flexion system with 24Vdc electric motor/actuator. •
- Lumbar distraction system with 24Vdc electric motor/actuator.
- Manual drops system.
- Manual adjustment of the articulated headpiece.
-. Manual regulation of the dorso-lumbar release/breakaway.
-. Manual regulation of leg length. - Manual regulation of lateral flexion movement. ●
-. Wheel system for transportation.
AGILIS "PRO" multifunction physiotherapy table, only differs from the "Plus" model in that the lifting system is compensated by mechanical springs. which allows the time to raise the equipment to be shorter by having to exert less effort.
AGILIS "BASIC" multifunction physiotherapy table, this configuration is a simplification of the previous configurations since it does not have a lifting system. It has the following features:
- Flexion system with 24Vdc electric motor/actuator.
-. Lumbar distraction system with 24Vdc electric motor/actuator. - Manual adjustment of the articulated headpiece. ●
- Manual regulation of the dorso-lumbar release/breakaway. ●
- Manual regulation of leg length. ●
-. Manual regulation of lateral flexion movement. - Manual drop system
- Fixed height .
Dimensions:
-. Physiotherapy table: 65" to 73" length, 23" width - optional 26".
- Headpiece: width 18" wide x 13" long. Made up of 3 pieces: 1 (one) central piece to support the patient's face and 2 (two) sides.
- Upper dorsal sector: 23" wide x 6.5" long.
- Lumbar back sector: 23" wide x 9" long. o
- Pelvic sector and leg: 23" wide x 17" long and 23" x 6" long. ●
-. Extendable sector: 23" wide x 9" long.
Components:
- Electrical source, model: MEA-250A24C.
Accessories: - Set of belts and fastenings.
- Removable Armrest: This optional component consists of two armrests measuring 23.5" . inches x 6 inches each and an additional upholstery section measuring 23 inches' x 6 inches.
- Side supports: Comprising two lateral supports (right and left) and two belts with a fixed ● end and an adjustable end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device is contraindicated in patients under 22 years of age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing Summary:
The Multi-function Physical Therapy Table - Model AGILIS was tested to evaluate its safety and effectiveness based on the following standards:
Electrical Safety, Electromagnetic Compatibility:
- EN/IEC 60601 -1:2005 + AMD1:2012 + AMD2:2020 - Medical Electrical Equipment - Part I: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014 +AMD1:2020- Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
Performance Standard:
Performance Safety Testing - Load Application (static and dynamic) and Efficacy Testing - Functional Analysis tests on the AGILIS multifunction physiotherapy tables. An operational control is carried out on 100% of the manufactured tables before their release to the market.
Clinical Studies:
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
January 31, 2025
Marzzan Lucas Jorge % Jose Huerta Consultant Sanrubio. LLC 8345 Park Blvd, Apt 6310. Mailbox 289 Miami, Florida 33126
Re: K241193
Trade/Device Name: AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB Dated: January 3, 2025 Received: January 3, 2025
Dear Jose Huerta:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
AmberT. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241193
Device Name
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
Indications for Use (Describe)
AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the text 'K241193' in a simple, sans-serif font. The text is arranged horizontally, with the letter 'K' followed by the numbers '241193'. The text is black against a white background. The numbers are evenly spaced.
ALTH
510(K) SUMMARY
January 31, 2025
Administrative information
| Applicant | MARZZAN LUCAS JORGE
Gdor. Crespo 1333 - Rosario – CP2000 –
Santa Fe - Argentina. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Lucas Jorge Marzzan
Tel: +54 -3415 70 0725
e-mail: lmarzzan@gmail.com ; info@althery-tables.com |
| Consultant | Jose Huerta
SANRUBIO, LLC
8345 Park Blvd, Apt 6310. Mailbox 289,
Miami, FL 33126 USA
Tel. (786) 557-8049
e-mail: info@sanrubio.com |
Device name and classification
| Type of Submission: | Traditional |
|---|---|
| Device's Trade Name: | AGILIS - Multi-function Physical Therapy Table |
| Device's Common Name: | AGILIS - Multi-function Physical Therapy Table |
| Classification Name: | Table, Physical Therapy, Multi-Function |
| 510(k) Submitter: | MARZZAN LUCAS JORGE |
| Regulation Number: | 21CFR 890.5880 |
| Device Class: | II |
| Classification Panel: | Physical medicine |
| Product Code: | JFB |
Predicate information
| 510(K) number | K063034 |
|---|---|
| Applicant | HILL LABORATORIES CO. |
| Model name | AIR-FLEX WITH AUTO-DISTRACTION |
| Classification name | Table, Physical Therapy, Multi-Function |
| Classification Panel: | Physical medicine |
| Regulation Number: | 21CFR 890.5880 |
| Device Class: | II |
| Product Code: | JFB |
5
Image /page/5/Picture/0 description: The image shows the logo for ALTHERY. The logo consists of a stylized flame-like symbol above the word "ALTHERY" in a modern, sans-serif font. The flame symbol is composed of two curved, parallel lines that converge at the top, creating a sense of upward movement. The overall design is clean and minimalist, conveying a sense of sophistication and innovation.
Indications for Use
AGILIS is a multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies
Device Description
The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.
Manual operation systems:
- . Headpiece.
- . Extension of feet.
- Drops. .
- Dorso - lumbar release/breakaway
- Lateral Flexion. ●
Electrical operating systems:
- . Horizontal elevation.
- . Flexion of the lower limb sector.
- Extension or linear movement of the lower limb sector (distraction/traction).
Physiotherapy table models:
-
AGILIS "PLUS" multifunction physiotherapy table, is the most complete model in the line of physiotherapy tables and has the following features:
-
Lifting system with 24Vdc electric motor/actuator. .
-
Flexion system with 24Vdc electric motor/actuator. •
-
Lumbar distraction system with 24Vdc electric motor/actuator.
-
Manual drops system.
-
Manual adjustment of the articulated headpiece.
-
. Manual regulation of the dorso-lumbar release/breakaway.
-
. Manual regulation of leg length.
-
Manual regulation of lateral flexion movement. ●
-
. Wheel system for transportation.
6
-
AGILIS "PRO" multifunction physiotherapy table, only differs from the "Plus" model in that the lifting system is compensated by mechanical springs. which allows the time to raise the equipment to be shorter by having to exert less effort.
-
AGILIS "BASIC" multifunction physiotherapy table, this configuration is a simplification of the previous configurations since it does not have a lifting system. It has the following features:
-
Flexion system with 24Vdc electric motor/actuator.
-
. Lumbar distraction system with 24Vdc electric motor/actuator.
-
Manual adjustment of the articulated headpiece. ●
-
Manual regulation of the dorso-lumbar release/breakaway. ●
-
Manual regulation of leg length. ●
-
. Manual regulation of lateral flexion movement.
-
Manual drop system
-
Fixed height .
Dimensions:
- . Physiotherapy table: 65" to 73" length, 23" width - optional 26".
- Headpiece: width 18" wide x 13" long. Made up of 3 pieces: 1 (one) central piece to support the patient's face and 2 (two) sides.
- Upper dorsal sector: 23" wide x 6.5" long.
- Lumbar back sector: 23" wide x 9" long. o
- Pelvic sector and leg: 23" wide x 17" long and 23" x 6" long. ●
- . Extendable sector: 23" wide x 9" long.
Components:
- Electrical source, model: MEA-250A24C.
Accessories:
- Set of belts and fastenings.
- Removable Armrest: This optional component consists of two armrests measuring 23.5" . inches x 6 inches each and an additional upholstery section measuring 23 inches' x 6 inches.
- Side supports: Comprising two lateral supports (right and left) and two belts with a fixed ● end and an adjustable end.
Contraindications:
Use of the chiropractic table is contraindicated in the following situations:
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Image /page/7/Picture/0 description: The image shows the logo for Althery. The logo consists of a stylized flame-like symbol above the word "ALTHERY" in a modern, sans-serif font. The flame symbol is composed of two curved lines that converge at the top, creating a sense of upward movement.
- . Patients under 22 years of age or weighing less than 100 lbs., where the force applied may be inappropriate for their body weight or developmental stage.
- . Patients with severe osteoporosis, where bones are highly fragile and susceptible to fractures under mechanical force.
- Recent spinal surgery or spinal fractures, where mechanical adjustments or traction could disrupt healing or cause further injury.
- Tumors, infections, or fractures of the spine, where mechanical force could exacerbate the condition or cause undue stress to affected areas.
- . Severe psychiatric disorders, such as depression where the condition could affect the patient's ability to cooperate during treatment or pose a safety concern.
- Liver and renal dysfunction, which may limit the patient's ability to recover or handle • physical therapy.
- Patients with cardiac failure, where high-force adjustments may pose a risk to • cardiovascular health.
- Pregnancy, especially in later stages, where mechanical traction or significant force on the ● abdominal area should be avoided.
- Patients with a history of cerebrovascular accidents (CVA) or myocardial infarctions . within the last six months, where the application of physical stress may trigger complications.
Additional exclusion criteria include patients with LBP caused by tumors, infections, or fractures; those with previous back surgery; severe osteoporosis; psychiatric disorders (e.g. schizophrenia); liver or renal dysfunction; pregnancy; medication for cardiac failure; a history of CVA or myocardial infarction within six months; and those deemed unsuitable for traction by the attending physician.
As always, consult the patient's overall medical history and perform a thorough evaluation before beginning chiropractic therapy, and adjust treatment parameters accordingly to ensure both safety and efficacy.
8
Image /page/8/Picture/0 description: The image shows the logo for Althery. The logo consists of a stylized flame-like symbol above the word "ALTHERY" in a modern, sans-serif font. The flame symbol is composed of two curved, parallel lines that converge at the top, creating a sleek and abstract design.
| Feature | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| General characteristics | |||
| Name | AGILIS | AIR FLEX with auto distraction | - |
| 510(K) number | K241193 | K063034 | - |
| Class | II | II | Same |
| Product code | JFB | JFB | Same |
| Regulation | 21 CFR 890.5880 | 21 CFR 890.5880 | Same |
| Indications for Use | AGILIS is a multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies | The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. | Same |
| Dimensions | Length 65" to 73" - width 23", optional 26". | Length 68" to 77" - width 24", optional 27". | |
| Not declared in version I of this device, the measurements represented here were obtained from version II of the predicate device. | Similar - The difference between the specification does not generate or modify the risks already established for this type of devices. | ||
| Product weight | 330 lbs. without accessories | 250 lbs. | Similar - The difference between the specification does not generate or modify the risks already established for this type of devices. |
| Materials | Vinyl | Vinyl | Same |
| Technological characteristics | |||
| Electrical operation | 24Vdc | 24 Vdc | Same |
| Abdominal decompression | Yes | Yes | Similar - The difference between the specification does not generate or modify the risks already established for this type of devices. |
| Headpiece | Manual and mechanical operation system with multiple positions: prone, supine, and lateral position. | Manual or air-drop drive system | Similar - The difference between the specification does not generate or modify the risks already |
| Range of motion: | |||
| Flexion: 20 degrees when in | |||
| the uppermost position. |
Extension: 15 degrees when
in the lowest position | Angle: 30° positive or negative.
Movements: Drops, lateral
flexion, and flexion. | risks already
established for this type
of devices. |
| Lateral motion | Free movement of 15° to
each side. It can also be left
fixed every 2.5°.
Lateral Flexion with locking
mechanisms. | Rotation and Lateral
Flexion with locking
mechanisms, up to 21°. | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Arm rest | Yes | Yes | Same |
| Feet extension | Length 65" a 73", | Length 68" to 77"
Not declared in version I of this
device, the measurements
represented here were obtained
from version II of the predicate
device. | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Emergency stop | 2 emergency stops (user and
operator)
Visual alarm system | 2 emergency stops (user
and operator)
Alarm system | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Drop system | 6 drops: 2 cervical, 1 upper
dorsal, 1 lumbar dorsum, 1
sacral, and 1 ankle.
Manual operation | 5 drops: thoracic, lumbar,
pelvic, cervical.
Pneumatic actuation | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Traction system | Electric actuators system | Pneumatic actuators
system | Similar - the
differences are
analyzed in the
following paragraph
"substantial
equivalence (SE) -
rationale" |
| Flexion system | Electric actuators system | Pneumatic actuators
system and manual flexion
system | Similar - the
differences are
analyzed in the
following paragraph
"substantial |
| | | | equivalence (SE) - rationale" |
| Lifting capacity - with lying patient | 450 pounds | 450 pounds | Same |
| Height
regulation: | Agilis Plus:21.5" – 29.5"
Agilis Pro: 21.5" – 31" | 21.5"-28" or 22.5"-29" | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| | Agilis Care: fixed height in
20", 25" or 30" | | |
| Display | Touchscreen Control | Touchscreen Control | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Pedals | Height Pedal | Corded Height Pedal
Optional Rocker Foot
Pedal
Power Foot Strips for
activating Airdrops
(optional)
Air-Pressure Foot Pedal 1 | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Air system | Not include | Air Tank
Power and Air-Drop
Control Panel | Different - The
difference between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| Accessories | Set of belts and fastenings.
Removable Armrest
Side Supports | Seatbelt
Ankle straps | Similar - The difference
between the
specification does not
generate or modify the
risks already
established for this type
of devices. |
| | | | |
| Safety and performance testing | | | |
| Non-clinical
testing | EN/IEC 60601 -1:2005 +
AMD1:2012 + AMD2:2020 -
Medical Electrical
Equipment - Part I: General
Requirements for Basic
Safety and Essential | IEC 60601-1 Medical
Electrical Equipment- Part
1: General Requirements
for Safety | Similar |
Substantial equivalence comparison
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Image /page/9/Picture/0 description: The image shows the logo for Althery. The logo consists of the word "ALTHERY" in a stylized font, with a symbol above it. The symbol resembles a flame or a stylized leaf with three curved segments.
10
Image /page/10/Picture/0 description: The image shows the logo for ALTHERY. Above the text "ALTHERY" is a stylized image of a flame. The flame is black and white and appears to be made of two curved lines.
11
Image /page/11/Picture/0 description: The image shows the logo for ALTHERY. The logo consists of a stylized flame-like symbol above the word "ALTHERY" in a sans-serif font. The flame symbol is made up of three curved lines that converge at the top, resembling a stylized flame or plume. The word "ALTHERY" is written in all capital letters, with a slightly curved line extending from the right side of the "Y".
| | IEC 60601-1-2:2014
+AMD1:2020- Medical
Electrical Equipment - Part 1-
2: General Requirements for
Basic Safety and Essential
Performance - Collateral
Standard: Electromagnetic
Compatibility - Requirements
and Tests. |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Substantial equivalence (SE) - rationale
The main features and differences found between the devices are summarized below:
- -The proposed device shares the same or similar basic characteristics and the same general use in physical medicine as the predicate device.
- -The product code (JFB) and Indications for Use between the predicate device and the proposed device is the same: multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion, and muscle relaxation therapy.
- The proposed device operates on AC to bring the motors voltage to 24 volts DC in the same manner as the AIR FLEX predicate device cleared under K063064. The power is through an external source for medical use.
- The proposed device, as the predicate, allows the automatic cycle of the distraction (traction) and flexion process in a specific period of time with multiple configurable parameters. These automatic cycles are controlled by a microprocessor on both devices.
- The proposed device, as the predicate device, has an emergency stop mechanism accessible to the patient in case the patient feels discomfort. On both devices this mechanism interrupts the operation, and the patient cannot reactivate the operation by himself, the operation must be reactivated by the qualified operator.
- -The materials used in the construction of the device, including the structure and upholstery, are similar.
- The predicated device, as the proposed device, has an alarm system that is activated when the emergency stop is activated; none of the devices allow the patient to reactivate the operation of the device without intervention of the professional operator. The predicate device has an audible alarm, while the proposed device has a visual alarm system through the device screen. This difference does not affect the safety and effectiveness of the device.
Main differences between technological features:
- -The predicated device uses pneumatic actuators for traction and flexion of the device components. while the proposed device uses electric motors to achieve the same result. This difference in the proposed device is for the purpose of minimizing the dependence of the actuator systems on each other, minimizing the possibility of a generalized failure occurring in all the systems
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in the tables. leaving it unusable and avoiding the potential failure of the established parameters and that could potentially generate sudden movements due to changes in loading conditions. By working with electric actuators, the independence of each actuator system is achieved, avoiding a generalized failure and at the same time guaranteeing that without power, the load cannot generate unexpected movements.
This difference does not affect the safety and effectiveness of the device.
- The predicated device has a system of 5 drops located in the thoracic, lumbar, pelvic and 2 cervical areas, the proposed device includes 6 drops located as follows: 2 cervical, 1 upper dorsal, 1 lumbar dorsum, 1 sacrum, and 1 ankle. The proposed device adds an ankle drop, which has the same operating mechanism as cervical drops, the risks being those already known, analyzed, and minimized for this type of devices.
This difference does not affect the safety and effectiveness of the device.
Therefore, the proposed device is considered by MARZZAN LUCAS JORGE to be Substantially Equivalent to the predicate device.
Non-Clinical Testing Summary
The Multi-function Physical Therapy Table - Model AGILIS was tested to evaluate its safety and effectiveness based on the following standards:
Electrical Safety, Electromagnetic Compatibility:
- . EN/IEC 60601 -1:2005 + AMD1:2012 + AMD2:2020 - Medical Electrical Equipment - Part I: General Requirements for Basic Safety and Essential Performance.
- . IEC 60601-1-2:2014 +AMD1:2020- Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
Performance Standard
Since there are no mandatory standards for these type of devices, "MARZZAN LUCAS JORGE" decided to adhere to the FDA guidelines outlined in the guidance document 'Recommended content and format of non-clinical bench performance testing in premarket submissions - Guidance for industry personnel and the Food and Drug Administration', and has performance Safety Testing - Load Application (static and dynamic) and Efficacy Testing - Functional Analysis tests on the AGILIS multifunction physiotherapy tables.
Furthermore, in order to guarantee the correct functioning, safety and effectiveness of the physiotherapy tables, an operational control is carried out on 100% of the manufactured tables before their release to the market, according to the procedures described in this submission.
Software
After a comprehensive evaluation that considered: the device. its Indications for Use. software analysis, known or foreseeable software hazards, and dangerous situations associated with the device, including those that could result from misuse, whether intentional or not, and the impact that these
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could have on the patient or user, it was determined that the Software documentation level evaluation is Basic Documentation.
The software information is provided in accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions".
Animal Study
No animal studies were considered necessary and performed.
Clinical Studies
No clinical studies were considered necessary and performed.
Conclusion
The proposed device is substantially equivalent to the currently marketed and predicate device in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 60601-1, IEC 60601-1-2, and bench testing.
The results of these tests demonstrate that the proposed device meets the acceptance criteria and is adequate for this Indications for Use. The comparison of technological characteristics, non-clinical performance data, electrical safety and electromagnetic compatibility testing demonstrates that the device is substantially equivalent to the previously cleared predicate devices.