JTL-250-01

{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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary # General Information | Submitter | Jointechlabs, Inc. | |-----------------------|------------------------------------------------------| | 510(k) Number | K182732 | | Address | 8 Graystone Court<br>North Barrington, IL 60010 | | Correspondence Person | Thomas Lawson, PhD<br>Director, Regulatory Affairs | | Contact Information | Email: drthomlawson@gmail.com<br>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<br>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<br>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: - 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; - 2. Both devices have mechanics that facilitate mixing and filtering of the tissue to a point where the tissue can be implanted; and - 3. Both devices are made from biocompatible materials. {5}------------------------------------------------ = | | Jointech Labs, Inc JTL-250-01<br>Proposed Device, K182732 | Lipogems International<br>SpA Lipogems System, K161636 | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>For Use | The JTL Tissue Processing<br>Device is a sterile medical<br>device intended for the<br>processing of lipoaspirate<br>tissue in medical procedures<br>involving the harvesting,<br>concentrating and transferring<br>of autologous adipose tissue<br>harvested with a legally<br>marketed lipoplasty system.<br>The device is intended for use<br>in the following surgical<br>specialties when the transfer of<br>harvested adipose tissue is<br>desired: orthopedic surgery,<br>arthroscopic surgery,<br>neurosurgery, gastrointestinal<br>and affiliated organ surgery,<br>urological surgery, general<br>surgery, gynecological surgery,<br>thoracic surgery, laparoscopic<br>surgery, and plastic and<br>reconstructive surgery when<br>aesthetic body contouring is<br>desired. Only legally marketed<br>accessory items, such as<br>syringes, should be used with<br>the system. If harvested fat is to<br>be re- implanted, the harvested<br>fat is only to be used without<br>any additional manipulation. | The Lipogems System is a<br>sterile medical device intended<br>for the closed-loop processing<br>of lipoaspirate tissue in medica<br>procedures involving the<br>harvesting, concentrating and<br>transferring of autologous<br>adipose tissue harvested with a<br>legally marketed lipoplasty<br>system. The device is intended<br>for use in the following<br>surgical specialties when the<br>transfer of harvested adipose<br>tissue is desired: orthopedic<br>surgery, arthroscopic surgery,<br>neurosurgery, gastrointestinal<br>and affiliated organ surgery,<br>urological surgery, general<br>surgery, gynecological surgery,<br>thoracic surgery, laparoscopic<br>surgery, and plastic and<br>reconstructive surgery when<br>aesthetic body contouring is<br>desired. Only legally marketed<br>accessory items, such as<br>syringes, should be used with<br>the system. If harvested fat is to<br>be transferred, the harvested fat<br>is only to be used without any<br>additional manipulation. | | Intended<br>Use | To process lipoaspirate fat<br>tissue intended for autologous<br>homofunctional implant<br>(lipofilling) | To process lipoaspirate fat<br>tissue intended for autologous<br>homofunctional implant<br>(lipofilling) | | Site of use | Hospitals | Hospitals | | Technical<br>Features | | | | Components | Pre-assembled centrifuge tube<br>with filters for microfracturing<br>of adipose tissue | Pre-assembled cylinder<br>containing filters and stainless<br>steel beads for microfracturing<br>of adipose tissue<br>Syringes Tubing | | | | Waste Collection Bag | | System<br>Concept | Closed Loop | Closed Loop | | Fill Volume | Up to 120 mL of fat | Up to 120 mL of fat | | Mechanics<br>of Tissue<br>Separation<br>Action | Filtering and microfracturing<br>by spinning the tube in a<br>centrifuge so that the material<br>separates as it moves through<br>various filters | Filtering and microfracturing<br>by physical shaking of the<br>cylinder and then hanging the<br>cylinder in reverse orientation<br>so that the material moves<br>through filters by gravity | | Provided<br>Sterile | Yes | Yes | | Sterilizing<br>agent | Radiation | Ethylene Oxide | | Sterility<br>Assurance<br>Level | 10-6 | 10-6 | | Single Use | Yes | Yes | | Duration of<br>use | ≤ 24 hours | ≤ 24 hours | | Tissue<br>contact<br>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.