(30 days)
Not Found
No
The description focuses on mechanical compression and pressure control, with no mention of AI or ML terms, data analysis, or learning capabilities.
Yes
The device is described as being "intended for the treatment of" various medical conditions and provides "compression" through "sequential pneumatic compression technique" which are characteristics of a therapeutic device.
No
The device is described as a "compression device" used for the "treatment" of various conditions, applying pneumatic pressure. There is no mention of it being used to diagnose or detect medical conditions.
No
The device description explicitly details hardware components including a pump device, air inflatable sleeves, air hose, connectors, a pressure control unit, power switch, and wall power connection. It is a physical compression system, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The medi pneumatic compression system (pcs) genius is a physical compression device that applies external pressure to the body. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed (Lymphedema, Venous stasis ulcers, Venous insufficiency, Peripheral edema) are conditions treated by physical means, not diagnosed or monitored through in vitro testing.
- Device Description: The description details a pump, air hose, and inflatable sleeves, all components of a physical therapy or treatment device, not an IVD.
Therefore, the medi pneumatic compression system (pcs) genius falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The medi pneumatic compression system (pcs) genius is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The medi pneumatic compression system (pcs) genius (Model 652) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.
The medi pcs genius (Model 652) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable sleeves with air hose and connectors, a power switch, and a wall power connection for standard 125v AC Power. The PCU provides compression in cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6, 8, or 10 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs genius (Model 652) is adjustable and limits the different treatment pressures and treatment times according to clinician prescription.
The medi pcs genius (Model 652) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs genius (Model 652) device, air hoses and air inflatable sleeves together may only be distributed, sold, and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeve(s) that are non-sterile and single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected extremity of the patient (upper and lower)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, and hospital use.
Professional users and non-medical operators.
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 was performed including:
- Sterilization: The device is provided non-sterile.
- Shelf-Life: Accelerated aging studies demonstrated the PCU, sleeves, and connectors remain functional for a minimum of 5 years.
- Biocompatibility testing: Cytotoxicity, Sensitization, and Irritation studies were conducted on the exterior sleeve material according to ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards and GLP (21 CFR Part 58). Results demonstrated conformance to all standards.
- Electrical safety and electromagnetic compatibility (EMC): The device conforms to ANSI/AAMI 60601-1, ANSI/AAMI 60601-1-11, and IEC 60601-1-2.
- Software Verification and Validation: Conforms to IEC 62304:2006 for a moderate level of concern.
- Bench Performance: Assessment of Inflation and Deflation Time, Treatment Time, Pressure, Burst Pressure, Pressure Gradient, Software Integration Graphical User Interface Navigation, Software Integration - Pressure Calibration, Safety Errors & Alarm, Packaging Test, and Use Life Test Performance.
- Summative Usability: Usability testing and evaluation confirmed the Operators Manual is appropriate for both professional users and non-medical operators.
Key Results: Performance testing results for the proposed device do not raise any new safety and/or effectiveness issues.
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2022
medi USA, L.P. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K221654
Trade/Device Name: medi pneumatic compression system (pcs)-genius (Model 652) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: June 6, 2022 Received: June 7, 2022
Dear Prithul Bom:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely,
for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
medi pneumatic compression system (pcs) - genius (Model 652)
Indications for Use (Describe)
The medi pneumatic compression system (pcs) genius is a compression device based on sequential neumatic compression technique which is intended for the treatment of the following conditions:
-Lymphedema
-Venous stasis ulcers
-Venous insufficiency
-Peripheral edema
The device is intended for home, and hospital use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Section 5
510k SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
I. SUBMITTER
medi USA, LP 6481 Franz Warner Pkwy. Whitsett, NC 27377
Phone: (336) 449-4440 Fax: (336) 446-1609
Contact: Moses Lipshaw Date Prepared: April 6, 2022
II. DEVICE
Name of Device: medi pneumatic compression system (pcs) genius (Model 652)
Common or Usual Name: Compressible Limb Sleeve
Classification Name: Compressible Limb Sleeve (21 CFR 870.5800) Requlatory Class: II Product Code: JOW
III. PREDICATE DEVICE
Name of Device: medi pneumatic compression system (pcs) - brio (Model 651) (K183631)
Common or Usual Name: Compressible Limb Sleeve
Classification Name: Compressible Limb Sleeve (21 CFR 870.5800) Requiatory Class: II Product Code: JOW
The predicate device has not been subject to a design-related recall.
IV.DEVICE DESCRIPTION
The medi pneumatic compression system (pcs) genius (Model 652) system consists of a medi pcs pump device a medi pcs air inflatable sleeve with air hose and connectors. The pump device, air hose, and sleeves are all non-sterile and single patient use.
The medi pcs genius (Model 652) device is an intermittent mechanical gradient compression pump that includes a pressure control unit (PCU) with two connection points for air inflatable
4
sleeves with air hose and connectors, a power switch, and a wall power connection for standard 125v AC Power. The PCU provides compression in cycles of pneumatic pressure applied in short, steady cycles. The air compressor distributes calibrated gradient pressure through a series of regulators to original compression sleeves containing either 6, 8, or 10 inflatable chambers to be externally applied over the affected extremity of the patient. The medi pcs genius (Model 652) is adjustable and limits the different treatment pressures and treatment times according to clinician prescription.
The medi pcs genius (Model 652) is used exclusively with air hose and medi pcs compression sleeves to fit both the upper and lower extremities. The medi pcs genius (Model 652) device, air hoses and air inflatable sleeves together may only be distributed, sold, and operated as a prescribed device. The device must be operated only with a new, original manufacturer limb sleeve(s) that are non-sterile and single patient use.
V. INDICATIONS FOR USE
The medi pneumatic compression system (pcs) genius is a compression device based on sequential pneumatic compression technique which is intended for the following conditions:
- -Lymphedema -Venous stasis ulcers -Venous insufficiency -Peripheral edema
The device is intended for home, and hospital use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Description | Subject Device: | Predicate: |
|---|---|---|
| medi pcs genius (Model 652) | medi pcs brio (Model 651) | |
| 510(k) | TBD (assigned by FDA) | K183631 |
| Medical Device | Same | Class II |
| Classification | Same | |
| Product Code | Same | JOW |
| Regulation Classification | Same | 870.5800 |
| Review Panel | Same | Cardiovascular |
| Intended Use | Same | Intermittent Sequential Pneumatic |
| Compression | ||
| Indications for Use | Same | The medi pneumatic compression |
| system (pcs) is a compression | ||
| device based on sequential | ||
| pneumatic compression technique | ||
| which is intended for the treatment | ||
| of the following conditions: | ||
| -Lymphedema | ||
| -Venous stasis ulcers |
5
| | | -Venous insufficiency
-Peripheral edema |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | | |
| | | The device is intended for home,
and hospital use |
| | | |
| Prescription Use Only | Same | Yes |
| Compression Type | Adjustable Distal Pressure &
Gradient
Sequential or Peristaltic
Adjustable pressure by chamber | Adjustable Distal Pressure &
Gradient
Sequential |
| Regulation Description | Same | Compressible Limb Sleeve |
| Mode | Same | Continuous |
| # of Inflatable Sleeve
Chambers | 6, 8, or 10 per sleeve | 6 or 8 per sleeve |
| Pump Distal Sleeve
Chamber Pressure
Range | 20 – 100 mmHg | 20 – 80 mmHg |
| Default Distal Sleeve
Chamber Pressure | Same | 50 mmHg Distal |
| Inflation time | 1-5 seconds per chamber,
dependent on pressure setting &
sleeve size | 3-5 seconds per chamber,
dependent on pressure setting &
sleeve size |
| Deflation time | Pressure based, deflates to
10mmHg or lower. | Time based, 10 seconds |
| Cycle Time | Sequential: 15-38 seconds,
Peristaltic: 50-170 seconds,
dependent on pressure settings
and sleeve model(s). | Sequential: 28-46 seconds,
dependent on pressure settings and
sleeve model(s). |
| Therapy Time | Same | Adjustable, 10 – 180 minutes |
| UL Mark | Same | Applied Part Type BF
Protection against Electrical Shock:
Class II |
| Standards | Same | IEC 60601-1, IEC 60601-1-2, IEC
60601-11, ISO 10993, ISO 14971,
IEC 62304, ISO 13485 |
| Single Patient Use | Same | Yes |
Adjustable distal pressure, gradient, sequential compression is the technological principle for both the subject and predicate device. Both compression systems are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Each compression systems are adjustable distal pressure, gradient, sequential type and enables different treatment pressures and treatment times according to clinician prescription.
At a high level, the subject and predicate device are based on the following same technological features and operational elements:
Similar pump with similar principals of operation
Similar sleeve design and materials
All devices consist of electrically generated sources of compressed air, tubing to convey the pressurized air to the sleeve and pressure is applied cyclically for a specified time period.
6
VII. NON-CLINICAL TESTING
The following performance data were provided in support of the substantial equivalence.
Sterilization
The medi pcs genius (Model 652) is provided non-sterile.
Shelf-Life
Accelerated aging studies were conducted on the pressure control unit (PCU), sleeves and connectors and demonstrated all remain functional for a minimum of 5 years supporting the medi pcs genius (model 652) shelf-life stability.
Biocompatibility testing
Biocompatibility tests were selected based on the 510(k) Memorandum - #G95-1 "Use of International Standard ISO-10993", Table 1 Initial Evaluation Tests for Consideration. Based on intended use and contact, the exterior sleeve material is considered a "Surface Device" for "Skin" and has a permanent cumulative contact duration of greater than 30 days when used for one hour daily over the course of a 3 year sleeve lifespan.
Based on the ISO 10993-1 testing matrix, Cytotoxicity, Sensitization, and Irritation studies were required and conducted on the exterior sleeve material according to the following ISO standards and Good Laboratory Practices (GLP), (21 CFR Part 58).
- AAM / ANSI / ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and . testing
- . AAMI / ANSI / ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- AAMI / ANSI / ISO 10993-10: Biological evaluation of medical devices -- Part 10: Tests for . irritation and sensitization
Results demonstrated conformance to all standards.
Electrical safety and electromagnetic compatibility (EMC)
The medi pcs qenius (Model 652) was tested and conforms to the following standards:
- . Electrical Safety General Requirements for basic safety and essential performance per ANSI/AAMI 60601-1
- Electrical Safety Collateral Standard per ANSI/AAMI 60601-1-11 ●
- EMC requirements and tests per IEC 60601-1-2 ●
Software Verification and Validation
The medi pcs genius (Model 652) conforms to the following standard, based on its identified moderate level of concern:
- IEC 62304:2006 Medical Device Software ●
7
Bench Performance
Bench and laboratory testing was performed and assures that the product meets its specifications. The sponsor believes that the technological characteristics of the medi pcs genius (Model 652) are substantially similar to those of the predicate device. The performance tests performed include assessment of:
- Inflation and Deflation Time Performance
- Treatment Time Performance ●
- Pressure Performance
- Burst Pressure Performance ●
- Pressure Gradient Performance ●
- Software Integration Graphical User Interface Navigation Performance ●
- Software Integration - Pressure Calibration Performance
- Safety Errors & Alarm Performance ●
- Packaging Test Performance ●
- Use Life Test Performance
Summative Usability
Usability testing and evaluation of end-users confirmed the medi pcs genius (Model 652) Operators Manual is appropriate and suitable for both professional users and non-medical operators for performing compression therapy based on sequential pneumatic compression technique.
VIII. CONCLUSION
Based on their same intended use, safety and performance testing results and the compliance with the acceptable voluntary standards and comparison to the predicate in terms of features and characteristics: we conclude that the proposed medi pcs genius (Model 652) is substantially equivalent to the identified predicate, since the subject device has the same technical and performance characteristics as the predicate device. Performance testing results for the proposed device do not raise any new safety and/or effectiveness issues.