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.

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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the JTL-250-01 Tissue Processing Device. This document focuses on demonstrating substantial equivalence to a predicate device (LipoGems System K161636) and does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets such criteria in terms of analytical or clinical performance of an AI/ML algorithm.

Therefore, many of the requested fields cannot be extracted from this document as they are typically associated with performance studies of diagnostic or prognostic devices, especially those involving AI/ML.

However, I can extract the information related to the device's characteristics and the general performance testing conducted to support its safety and effectiveness.

Here’s what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance in the context of an AI/ML algorithm's output (e.g., sensitivity, specificity, accuracy). Instead, it lists general performance testing categories.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Passed all tests: Cytotoxicity, Sensitization, Acute Systemic Toxicity, and Irritation. Materials have a long history in medical devices.
Electrical Safety & EMC	Not applicable, as there are no electronics or electrical elements in the device.
Software Verification & Validation	Not applicable, as there is no software in this device.
Mechanical Performance	Successful testing for: 12-month accelerated aging and package performance; Fat graft volume; Oil volume; Verification of functional design outputs; Performance assessment of JTL-250-01 and LGD 240 in producing viable and administrable fat tissue.
Sterility Assurance Level (SAL)	10-6
Duration of Use	≤ 24 hours
Tissue Contact Materials	Compliant with ISO 10993

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "mechanical testing" but does not specify the sample size of devices or the nature of the data (e.g., patient samples) used in these tests, nor their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and study described. There is no mention of expert ground truth establishment for a test set, as this is not an AI/ML diagnostic or prognostic device requiring such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No adjudication method is mentioned as there is no test set involving human interpretation needing adjudication for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" would likely be based on established engineering specifications, material science standards, and functional performance benchmarks (e.g., expected fat graft volume, oil separation efficiency). The document indicates "Verification testing of the functional design outputs for the device" and "Performance assessment... with respect to production of fat tissue that is viable and able to be administered". This suggests functional benchmarks were used, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable. There is no training set for an AI/ML algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K182732

Device Name JTL-250-01 Tissue Processing Device

Indications for Use (Describe)

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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510(k) Summary

General Information

Submitter	Jointechlabs, Inc.
510(k) Number	K182732
Address	8 Graystone CourtNorth Barrington, IL 60010
Correspondence Person	Thomas Lawson, PhDDirector, Regulatory Affairs
Contact Information	Email: drthomlawson@gmail.comPhone: 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 andClassification 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 andClassification 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.

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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:

1. 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;
1. Both devices have mechanics that facilitate mixing and filtering of the tissue to a point where the tissue can be implanted; and
1. Both devices are made from biocompatible materials.

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	Jointech Labs, Inc JTL-250-01Proposed Device, K182732	Lipogems InternationalSpA Lipogems System, K161636
IndicationsFor Use	The JTL Tissue ProcessingDevice is a sterile medicaldevice intended for theprocessing of lipoaspiratetissue in medical proceduresinvolving the harvesting,concentrating and transferringof autologous adipose tissueharvested with a legallymarketed lipoplasty system.The device is intended for usein the following surgicalspecialties when the transfer ofharvested adipose tissue isdesired: orthopedic surgery,arthroscopic surgery,neurosurgery, gastrointestinaland affiliated organ surgery,urological surgery, generalsurgery, gynecological surgery,thoracic surgery, laparoscopicsurgery, and plastic andreconstructive surgery whenaesthetic body contouring isdesired. Only legally marketedaccessory items, such assyringes, should be used withthe system. If harvested fat is tobe re- implanted, the harvestedfat is only to be used withoutany additional manipulation.	The Lipogems System is asterile medical device intendedfor the closed-loop processingof lipoaspirate tissue in medicaprocedures involving theharvesting, concentrating andtransferring of autologousadipose tissue harvested with alegally marketed lipoplastysystem. The device is intendedfor use in the followingsurgical specialties when thetransfer of harvested adiposetissue is desired: orthopedicsurgery, arthroscopic surgery,neurosurgery, gastrointestinaland affiliated organ surgery,urological surgery, generalsurgery, gynecological surgery,thoracic surgery, laparoscopicsurgery, and plastic andreconstructive surgery whenaesthetic body contouring isdesired. Only legally marketedaccessory items, such assyringes, should be used withthe system. If harvested fat is tobe transferred, the harvested fatis only to be used without anyadditional manipulation.
IntendedUse	To process lipoaspirate fattissue intended for autologoushomofunctional implant(lipofilling)	To process lipoaspirate fattissue intended for autologoushomofunctional implant(lipofilling)
Site of use	Hospitals	Hospitals
TechnicalFeatures
Components	Pre-assembled centrifuge tubewith filters for microfracturingof adipose tissue	Pre-assembled cylindercontaining filters and stainlesssteel beads for microfracturingof adipose tissueSyringes Tubing
		Waste Collection Bag
SystemConcept	Closed Loop	Closed Loop
Fill Volume	Up to 120 mL of fat	Up to 120 mL of fat
Mechanicsof TissueSeparationAction	Filtering and microfracturingby spinning the tube in acentrifuge so that the materialseparates as it moves throughvarious filters	Filtering and microfracturingby physical shaking of thecylinder and then hanging thecylinder in reverse orientationso that the material movesthrough filters by gravity
ProvidedSterile	Yes	Yes
Sterilizingagent	Radiation	Ethylene Oxide
SterilityAssuranceLevel	10-6	10-6
Single Use	Yes	Yes
Duration ofuse	≤ 24 hours	≤ 24 hours
Tissuecontactmaterials	Compliant with ISO 10993	Compliant with ISO 10993

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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.

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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.

Regulation Number and Section

§ 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.