Dermapose Access

{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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Puregraft LLC Olivia Kim RA/QA Director 420 Stevens Avenue, Suite 220 Solana Beach, California 92075 June 9, 2021 Re: K200168 Trade/Device Name: Dermapose Access Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB Dear Olivia Kim: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 22, 2020. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov. Sincerely, # Cindy Chowdhury -S Cindy Chowdhury, Ph.D., M.B.A. 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue rectangle with the letters "FDA" in white. To the right of the rectangle, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. April 22, 2020 Puregraft LLC Olivia Kim RA/QA Director 420 Stevens Avenue, Suite 220 Solana Beach, California 92075 ## Re: K200168 Trade/Device Name: Dermapose Access Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: January 21, 2020 Received: January 23, 2020 Dear Olivia Kim: 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 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 {2}------------------------------------------------ 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 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, Image /page/2/Picture/5 description: The image shows the name "Joseph A. Nielsen" in a large, bold font. To the right of the name is a digital signature block. The signature block includes information such as the DN, OU, email, country, and date of the signature. Digitally signed by Joseph A. Nielser A/CDRH/ODF/DSD/PRSB1. 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200168 Device Name Dermapose Access Indications for Use (Describe) The Dermapose Access fat harvest system is intended for use in aesthetic body contouring. 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." {4}------------------------------------------------ #### 510(k) Summary # Submitter Information | Applicant Name: | Puregraft LLC<br>420 Stevens Avenue, Suite 220<br>Solana Beach, CA 92075 USA | |------------------|-----------------------------------------------------------------------------------------------------------| | Company Contact: | Olivia Kim<br>RA/QA Director<br>Phone: (858) 386-4140<br>Fax: (858) 217-5134<br>Email: okim@puregraft.com | Date Prepared: April 20, 2020 #### Device Information | Submission Number: | K200168 | |-----------------------------|-----------------------------| | Trade or Proprietary Name: | Dermapose™ Access | | Common Name: | Suction lipoplasty system | | Device Classification Name: | System, Suction, Lipoplasty | | Product Code: | MUU | | Regulatory Class: | Class II | | Classification Regulation: | 21 CFR 878.5040 | | Panel: | General & Plastic Surgery | #### Predicate Device st'rim, K142073, Thiebaud SAS #### Indications for Use The Dermapose™ Access fat harvest system is intended for use in aesthetic body contouring. #### Device Description The Dermapose™ Access is a pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest. The following are provided sterile with the Dermapose™ Access: {5}------------------------------------------------ - A pre-assembled polycarbonate housing with a linear needle guidance system and a 12G x ● 51 mm lancet point needle to allow passage of a 14G cannula through the bore; - A 14G x 150 mm Harvesting/Tumescent Cannula; and - A silicone tube set with regulator valve, which connects to a user-provided vacuum source o The Dermapose™ Access is also intended to be used with a user-provided vacuum pump capable of at least 18 inHg (60 kPa) of vacuum in order to lift the patient's skin into the guide cavity. The pump should have a standard barb fitting of approximately 1/4 inch. The use of a collection canister is recommended but is not necessary as fluid should not enter the tubing. To protect the pump from possible fluid ingress, the Dermapose™ Access includes a protective filter. ## Technological Characteristics The Dermapose™ Access is substantially equivalent to the predicate device, st'rim. A comparison of technological characteristics is provided in the table below. Both the subject device and the predicate device provide a method of cannula introduction for harvesting autologous adipose tissue. In addition, both the subject and predicate devices are provided sterile (via ethylene oxide) and intended for single use. | Device Name | Subject Device<br>Dermapose™ Access | Predicate Device<br>St'rim (K142073) | Similarity | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Indications for<br>Use | The Dermapose™ Access fat harvest<br>system is intended for use in aesthetic<br>body contouring. | The st'rim™ fat tissue harvest and<br>injection cannula set is intended for<br>use in aesthetic body contouring. | Identical | | User Environment | Physician | Physician | Identical | | Design Concept | Guided needle and cannula kit | Assorted needle and cannula kit | Different | | Components | 14G Harvest/Tumescent cannula 12G incision needle housed in a linear guidance and vacuum-assisted skin hold system. A silicone tube set for connection of vacuum | 14G Harvest/Tumescent cannula 14G incision needle 21G injection cannula (short) 21G injection cannula (long) 21G incision needle Luer-to-luer connector | Different | | Method of<br>Harvesting | Cannula (provided) and Syringe (user-provided) | Cannula (provided) and Syringe (user-provided) | Identical | | Incision | Guided incision | Non-guided incision (physician pinch) | Different | | Source of Harvest<br>Energy | None - Manual by operator | None - Manual by operator | Identical | | Source of Skin<br>Hold Energy | User provided vacuum source | None - Manual by operator (pinch) | Different | | Device performs<br>Harvesting | No – requires syringe capable of<br>holding vacuum | No - requires syringe capable of<br>holding vacuum | Identical | {6}------------------------------------------------ | Mechanical<br>operation (entry) | Needle incision followed by<br>concentric cannula introduction, then<br>needle removal | Needle incision, then needle removal,<br>followed by cannula introduction | Similar | |---------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------| | Mechanical<br>operation<br>(harvest) | Requires syringe capable of holding<br>vacuum, motion is back and forth and<br>sweeping about entry point | Requires syringe capable of holding<br>vacuum, motion is back and forth and<br>sweeping about entry point | Identical | | Mechanical<br>operation<br>(process) | Not part of system | Not part of system | Identical | | Mechanical<br>operation<br>(delivery) | Injection via small syringes and<br>injection cannula (not included) | Injection via small syringes (not<br>included) and injection cannula<br>(included) | Similar | | Construction | Preassembled except for luer<br>connections | Preassembled except for luer<br>connections | Identical | | Sterility | Supplied sterile for single use | Supplied sterile for single use | Identical | | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Identical | | Sterility<br>Assurance Level | SAL = 10-6 | SAL = 10-6 | Identical | | Biocompatibility | Biocompatible | Biocompatible | Identical | ## Performance Testing The Dermapose "1" Access was tested in accordance with established protocols and met the acceptance criteria for all tests performed. Performance testing included: - Skin Puncture Test: Evaluated the ability to penetrate skin using the Dermapose™ Access. ● - Reliability Test: Evaluated the reliability of the Dermapose™ Access. ● - Skin Hold and Needle Depth Analysis: Evaluated the performance of the Dermapose™ ● Access to hold and puncture skin. - Cannula Analysis: Evaluated the laboratory testing of the cannula provided with the ● Dermapose™ Access. Biocompatibility testing for the Dermapose™ Access was performed in accordance with the requirements of ISO 10993-1:2018 for external communicating devices having contact < 24 hours. In all instances, the test articles were found to be biocompatible. The battery of testing included the following tests: - Cytotoxicity per ISO 10993-5:2009 - Sensitization per ISO 10993-10:2010 ● - Intracutaneous per ISO 10993-10:2010 ● - Acute Systemic Toxicity per ISO 10993-11:2017 ● - Pyrogen Testing per ISO 10993-11:2017 ● - Determination of Extractable Elements per ISO 10993-18:2005 {7}------------------------------------------------ Human Factors and Usability Engineering was evaluated. The Dermapose™ Access was found to be safe and effective for the intended users, uses, and use environments. Sterilization of the Dermapose™ Access is conducted via the Single Lot Release Method by Ethylene Oxide according to Annex E: Single Lot Release of ISO 11135:2014/Amd.1:2018. The Dermapose "1 Access has an expiry date of 24 months based on integrity testing conducted post completion of accelerated aging and ISTA 2A ship testing. #### Statement of Substantial Equivalence Based on the information contained in this submission, it is concluded that the Dermapose™ Access is substantially equivalent to the predicate device, st'rim. The Dermapose™ Access has the same indications for use, as well as similar technological characteristics and principles of operation as its predicate device. Thus, the Dermapose™ Access is substantially equivalent to the st rim.