(416 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical function of a centrifuge tube for tissue processing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a tissue processing device intended for the processing of lipoaspirate tissue, not for directly treating or diagnosing a disease or condition. Its function is to prepare tissue for re-implantation, which is part of a larger medical procedure.
No
The JTL Tissue Processing Device is explicitly described for processing lipoaspirate tissue (harvesting, concentrating, transferring) for re-implantation, which is a therapeutic rather than a diagnostic function. It does not mention any function for identifying or analyzing diseases or conditions.
No
The device description clearly states it is a physical centrifuge tube made of biocompatible materials, intended for processing lipoaspirate tissue. It is a hardware device.
Based on the provided information, the JTL Tissue Processing Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for processing lipoaspirate tissue in medical procedures involving harvesting, concentrating, and transferring autologous adipose tissue. This is a procedural device used during a medical intervention on the patient's body.
- Device Description: The device is described as a centrifuge tube for processing tissue. It's a tool used to manipulate tissue outside the body, but it's part of a surgical procedure, not a diagnostic test.
- Lack of Diagnostic Purpose: The device does not perform any tests or analyses on the tissue to diagnose a condition, monitor a disease, or determine a patient's health status. Its purpose is to prepare the tissue for re-implantation.
- No Mention of Diagnostic Testing: The description of performance studies focuses on biocompatibility and mechanical performance, not on the accuracy or reliability of any diagnostic results.
In Vitro Diagnostics (IVDs) are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition. The JTL Tissue Processing Device does not fit this definition.
N/A
Intended Use / Indications for Use
The JTL Tissue Processing Device is a sterile medical device intended for the processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
The JTL-250-01 Tissue Processing Device is a centrifuge tube for processing lipoaspirate fat tissue that is intended for autologous homofunctional implant (lipofilling).
The device is a pre-assembled, single-use centrifuge tube composed of a collection upper chamber, intermediate chamber, and a lower chamber. The diameter of the JTL Tissue Processing Device is 4.2 inches at the top ring and 3.6 inches in the main body. It stands 4 inches tall. The device weighs less than 1 pound. The components of the device are made of biocompatible materials. The device is sterilized by radiation and is intended for single use only.
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
Not Found
Intended User / Care Setting
Used in a healthcare facility.
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)
Performance testing was conducted to establish that the JTL Tissue Processing Device does not raise new questions of safety or effectiveness.
- Biocompatibility testing: The device passed tests for cytotoxicity, sensitization, acute systemic toxicity, and irritation.
- Electrical safety and electromagnetic compatibility (EMC): Not applicable as there are no electronics or electrical elements in the device.
- Software Verification and Validation Testing: Not applicable as there is no software in the device.
- Mechanical Testing: Included 12-month accelerated aging and package performance testing; fat graft volume; oil volume; verification testing of the functional design outputs for the device; and performance assessment of the JTL-250-01 and the LGD 240 devices with respect to production of fat tissue that is viable and able to be administered during surgical procedures.
- Animal Testing: No animal testing was necessary.
- Clinical Studies: No clinical testing was necessary.
Conclusion: The device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device.
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
November 18, 2019
Jointechlabs, Inc. Thomas Lawson Director, Regulatory Affairs 8 Graystone Court North Barrington, Illinois 60010
Re: K182732
Trade/Device Name: Jtl-250-01 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: October 15, 2019 Received: October 17, 2019
Dear Dr. Thomas Lawson:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
Sincerely,
For Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182732
Device Name JTL-250-01 Tissue Processing Device
Indications for Use (Describe)
The JTL Tissue Processing Device is a sterile medical device intended for the processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
| 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)
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3
510(k) Summary
General Information
| Submitter | Jointechlabs, Inc. |
|---|---|
| 510(k) Number | K182732 |
| Address | 8 Graystone Court |
| North Barrington, IL 60010 | |
| Correspondence Person | Thomas Lawson, PhD |
| Director, Regulatory Affairs | |
| Contact Information | Email: drthomlawson@gmail.com |
| Phone: 510-206-1794 | |
| Date Prepared | 15 October 2019 |
Proposed Device
| Trade Name | Tissue Processing Device JTL-250-01 |
|---|---|
| Common Name | JTL-250-01 |
| Regulation Number and | |
| Classification Name | 21 CFR§878.5040 Suction Lipoplasty System |
| Product Code | MUU |
| Regulatory Class | II |
Predicate Device
| Trade Name | LipoGems System |
|---|---|
| Common Name | LipoGems 240 |
| Premarket Notification | K161636 |
| Regulation Number and | |
| Classification Name | 21 CFR§878.5040 Suction Lipoplasty System |
| Product Code | MUU |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. |
Device Description
The JTL-250-01 Tissue Processing Device is a centrifuge tube for processing lipoaspirate fat tissue that is intended for autologous homofunctional implant (lipofilling).
The device is a pre-assembled, single-use centrifuge tube composed of a collection upper chamber, intermediate chamber, and a lower chamber. The diameter of the JTL Tissue Processing Device is 4.2 inches at the top ring and 3.6 inches in the main body. It stands 4 inches tall. The device weighs less than 1 pound. The components of the device are made of biocompatible materials.
4
The device is sterilized by radiation and is intended for single use only.
The JTL Tissue Processing Device is to be used in a healthcare facility. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
Indications for Use
The JTL Tissue Processing Device is a sterile medical device intended for the processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Both the subject device and the predicate device have the same indication and intended use, which is to process lipoaspirate fat tissue intended for autologous homofunctional implant (lipofilling).
Comparison of Technological Characteristics with the Predicate Device and Subject Device
JoinTech Labs has identified the LipoGems System (K161636) as the predicate device. The JTL Tissue Processing Device is substantially equivalent to the predicate device based upon the following similarities:
-
- The intended use of both the predicate device and the JTL Tissue Processing Device is to process lipoaspirate fat tissue, with the result being a homogeneous and micronized fraction of fat tissue;
-
- Both devices have mechanics that facilitate mixing and filtering of the tissue to a point where the tissue can be implanted; and
-
- Both devices are made from biocompatible materials.
5
=
| | Jointech Labs, Inc JTL-250-01
Proposed Device, K182732 | Lipogems International
SpA Lipogems System, K161636 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | The JTL Tissue Processing
Device is a sterile medical
device intended for the
processing of lipoaspirate
tissue in medical procedures
involving the harvesting,
concentrating and transferring
of autologous adipose tissue
harvested with a legally
marketed lipoplasty system.
The device is intended for use
in the following surgical
specialties when the transfer of
harvested adipose tissue is
desired: orthopedic surgery,
arthroscopic surgery,
neurosurgery, gastrointestinal
and affiliated organ surgery,
urological surgery, general
surgery, gynecological surgery,
thoracic surgery, laparoscopic
surgery, and plastic and
reconstructive surgery when
aesthetic body contouring is
desired. Only legally marketed
accessory items, such as
syringes, should be used with
the system. If harvested fat is to
be re- implanted, the harvested
fat is only to be used without
any additional manipulation. | The Lipogems System is a
sterile medical device intended
for the closed-loop processing
of lipoaspirate tissue in medica
procedures involving the
harvesting, concentrating and
transferring of autologous
adipose tissue harvested with a
legally marketed lipoplasty
system. The device is intended
for use in the following
surgical specialties when the
transfer of harvested adipose
tissue is desired: orthopedic
surgery, arthroscopic surgery,
neurosurgery, gastrointestinal
and affiliated organ surgery,
urological surgery, general
surgery, gynecological surgery,
thoracic surgery, laparoscopic
surgery, and plastic and
reconstructive surgery when
aesthetic body contouring is
desired. Only legally marketed
accessory items, such as
syringes, should be used with
the system. If harvested fat is to
be transferred, the harvested fat
is only to be used without any
additional manipulation. |
| Intended
Use | To process lipoaspirate fat
tissue intended for autologous
homofunctional implant
(lipofilling) | To process lipoaspirate fat
tissue intended for autologous
homofunctional implant
(lipofilling) |
| Site of use | Hospitals | Hospitals |
| Technical
Features | | |
| Components | Pre-assembled centrifuge tube
with filters for microfracturing
of adipose tissue | Pre-assembled cylinder
containing filters and stainless
steel beads for microfracturing
of adipose tissue
Syringes Tubing |
| | | Waste Collection Bag |
| System
Concept | Closed Loop | Closed Loop |
| Fill Volume | Up to 120 mL of fat | Up to 120 mL of fat |
| Mechanics
of Tissue
Separation
Action | Filtering and microfracturing
by spinning the tube in a
centrifuge so that the material
separates as it moves through
various filters | Filtering and microfracturing
by physical shaking of the
cylinder and then hanging the
cylinder in reverse orientation
so that the material moves
through filters by gravity |
| Provided
Sterile | Yes | Yes |
| Sterilizing
agent | Radiation | Ethylene Oxide |
| Sterility
Assurance
Level | 10-6 | 10-6 |
| Single Use | Yes | Yes |
| Duration of
use | ≤ 24 hours | ≤ 24 hours |
| Tissue
contact
materials | Compliant with ISO 10993 | Compliant with ISO 10993 |
6
Performance Data
The performance testing conducted establishes that the JTL Tissue Processing Device does not raise new questions of the safety or effectiveness.
Biocompatibility testing
The JTL Tissue Processing Device is manufactured from materials with a long history in medical devices and passed all tests:
- o Cytotoxicity,
- o Sensitization,
- o Acute Systemic Toxicity, and
- 0 Irritation.
Electrical safety and electromagnetic compatibility (EMC)
There are no electronics or electrical elements in this device.
7
Software Verification and Validation Testing
There is no software in this device.
Mechanical Testing
The mechanical testing of the subject device included:
- 12-month accelerated aging and package performance testing; .
- . Fat graft volume;
- Oil volume; .
- . Verification testing of the functional design outputs for the device; and
- Performance assessment of the JTL-250-01 and the LGD 240 devices with respect to production of fat tissue that is viable and able to be administered during surgical procedures.
Animal Testing
No animal testing of the subject device was necessary.
Clinical Studies
No clinical testing of the subject device was necessary.
Conclusion
The information submitted in this premarket notification confirms that the Tissue Processing Device raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate device.