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:

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.

AI/ML Overview

The provided document is a 510(k) Summary for the Dermapose™ Access device, which is a fat harvest system. It discusses the device's substantial equivalence to a predicate device, st'rim. However, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific performance criteria in the format typically used for AI/ML device evaluations.

Instead, it lists performance testing categories and states that the device "met the acceptance criteria for all tests performed." It does not provide the quantitative acceptance criteria themselves or the detailed results of the tests.

Therefore, I cannot directly extract the comprehensive information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies for this medical device.

What can be extracted or inferred from the document:

The performance testing mentioned are:

Skin Puncture Test: Evaluated the ability to penetrate skin.
Reliability Test: Evaluated the reliability of the device.
Skin Hold and Needle Depth Analysis: Evaluated the performance of the device to hold and puncture skin.
Cannula Analysis: Evaluated the laboratory testing of the cannula provided.
Biocompatibility testing: Performed according to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Pyrogen Testing, Determination of Extractable Elements).
Human Factors and Usability Engineering.
Sterilization validation: According to ISO 11135:2014/Amd.1:2018.
Shelf life testing: Based on accelerated aging and ISTA 2A ship testing, resulting in a 24-month expiry date.

The document states that the Dermapose™ Access "met the acceptance criteria for all tests performed" and "was found to be safe and effective for the intended users, uses, and use environments."

Limitations of the provided text for your request:

Acceptance Criteria & Reported Performance: Not explicitly stated with quantitative values.
Sample Sizes: Not mentioned for any of the performance tests.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number/Qualifications of Experts: Not mentioned as these tests are likely laboratory or engineering tests, not expert-read image analysis.
Adjudication Method: Not applicable for the types of tests described.
MRMC Comparative Effectiveness Study: Not conducted or mentioned, as this is a physical medical device, not an AI/ML algorithm requiring human reader comparison.
Standalone Performance: Not explicitly detailed, but the performance tests listed are likely for the device in isolation or as intended for use by a single operator.
Type of Ground Truth: Not applicable in the context of AI/ML, as these are engineering and biocompatibility tests.
Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/ML algorithm.

In summary, the provided FDA 510(k) summary confirms that performance testing was conducted for the Dermapose™ Access device and the results met the acceptance criteria. However, it does not provide the specific quantitative acceptance criteria or detailed results required to complete your requested table and study description for an AI/ML device. The device described is a physical surgical tool, not an AI/ML software.

Summary

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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

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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

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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

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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)

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510(k) Summary

Submitter Information

Applicant Name:	Puregraft LLC420 Stevens Avenue, Suite 220Solana Beach, CA 92075 USA
Company Contact:	Olivia KimRA/QA DirectorPhone: (858) 386-4140Fax: (858) 217-5134Email: 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 following are provided sterile with the Dermapose™ Access:

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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

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 DeviceDermapose™ Access	Predicate DeviceSt'rim (K142073)	Similarity
Indications forUse	The Dermapose™ Access fat harvestsystem is intended for use in aestheticbody contouring.	The st'rim™ fat tissue harvest andinjection cannula set is intended foruse 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 ofHarvesting	Cannula (provided) and Syringe (user-provided)	Cannula (provided) and Syringe (user-provided)	Identical
Incision	Guided incision	Non-guided incision (physician pinch)	Different
Source of HarvestEnergy	None - Manual by operator	None - Manual by operator	Identical
Source of SkinHold Energy	User provided vacuum source	None - Manual by operator (pinch)	Different
Device performsHarvesting	No – requires syringe capable ofholding vacuum	No - requires syringe capable ofholding vacuum	Identical

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Mechanicaloperation (entry)	Needle incision followed byconcentric cannula introduction, thenneedle removal	Needle incision, then needle removal,followed by cannula introduction	Similar
Mechanicaloperation(harvest)	Requires syringe capable of holdingvacuum, motion is back and forth andsweeping about entry point	Requires syringe capable of holdingvacuum, motion is back and forth andsweeping about entry point	Identical
Mechanicaloperation(process)	Not part of system	Not part of system	Identical
Mechanicaloperation(delivery)	Injection via small syringes andinjection cannula (not included)	Injection via small syringes (notincluded) and injection cannula(included)	Similar
Construction	Preassembled except for luerconnections	Preassembled except for luerconnections	Identical
Sterility	Supplied sterile for single use	Supplied sterile for single use	Identical
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Identical
SterilityAssurance 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

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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.

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.