The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating 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, 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.

Device Description

The Dermapose Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use.

The Dermapose™ Refresh is comprised of the following:

50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe
Two 30 mL syringes
Three luer caps
Luer-to-luer adapter

The Dermapose™ Refresh is also intended to be used with Lactated Ringer's solution, injection syringes (1 or 3 mL recommended), injection cannulas (18-21G recommended), and luer-lock harvest cannula (14G recommended) which are provided by the user. Dermapose™ Refresh should be used in conjunction with the 510(k)-exempt Dermapose TM Refresh Stand.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dermapose Refresh device. It indicates that performance and biocompatibility testing were conducted, but it does not provide detailed acceptance criteria, reported performance values, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) for the performance testing.

Here's an analysis based on the information available:

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

The document states: "The Dermapose™ Refresh was tested in accordance with established protocols and met the acceptance criteria for all tests performed." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the tests mentioned.

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states that the device "met the acceptance criteria."	Not provided in the document. The document states that the device "met the acceptance criteria."

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

Sample Size for Test Set: Not provided. The document lists types of performance tests (Nucleated Cell Viability, Tissue Composition, System Leak, Mechanical Test), but does not specify the number of samples or runs for any of these tests.
Data Provenance: Not provided. The document does not specify the origin of the data (e.g., country) or whether the studies were retrospective or prospective.

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 as the described tests (cell viability, tissue composition, leak, mechanical) are objective laboratory or engineering tests, not studies requiring expert interpretation of images or patient data to establish ground truth.

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

This information is not applicable as there were no subjective assessments requiring adjudication described in the provided text.

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. The device, Dermapose Refresh, is a medical device for processing adipose tissue, not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

For the described performance tests:

Nucleated Cell Viability: The ground truth would be established by the measurements from the Luna-Stem Automated Fluorescence Cell Counter.
Tissue Composition: The ground truth would be established by analytical methods for assessing adipose tissue layers.
System Leak: The ground truth would be established by quantitative measurements of vacuum retention.
Mechanical Test: The ground truth would be established by engineering specifications and measurements of mechanical connections.

These are objective measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. The Dermapose Refresh is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable due to the nature of the device as explained in point 8.

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 Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 14, 2020

Puregraft LLC Olivia Kim RA/QA Director 420 Stevens Avenue, Suite 220 Solana Beach, California 92075

Re: K193363

Trade/Device Name: Dermapose Refresh Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: November 16, 2019 Received: December 4, 2019

Dear Ms. 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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,

Cindv Chowdhurv, 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) K193363

Device Name Dermapose Refresh

Indications for Use (Describe)

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
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Company Contact:	Olivia KimRA/QA DirectorPhone: (858) 386-4140Fax: (858) 217-5134Email: okim@puregraft.com
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Date Prepared: November 27, 2019

Device Information

Trade or Proprietary Name:	Dermapose™ Refresh
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

Lipogems System, K171135, Lipogems International SpA

Indications for Use

The Dermapose "11 Refresh is a sterile medical device intended for the closed-loop 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, 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 reimplanted, the harvested fat is only to be used without any additional manipulation.

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Device Description

The Dermapose 114 Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use.

The Dermapose™ Refresh is comprised of the following:

1. 50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe
1. Two 30 mL syringes
1. Three luer caps
1. Luer-to-luer adapter

Technological Characteristics

The Dermapose™ Refresh is substantially equivalent to the predicate device. A comparison of technological characteristics is provided in the table below. Both the subject device and the predicate device provide a method of harvesting, concentrating, and transferring of autologous adipose tissue. In addition, both the subject and predicate devices are pre-assembled systems which are provided sterile (via ethylene oxide) and intended for single use.

Device Name	Subject DeviceDermapose™ Refresh	Predicate DeviceLipogems System (K171135)
Indications for Use	The Dermapose™ Refresh is a sterile medicaldevice intended for the closed-loop processingof lipoaspirate tissue in medical proceduresinvolving the harvesting, concentrating andtransferring of autologous adipose tissueharvested with a legally marketed lipoplastysystem. The device is intended for use in thefollowing surgical specialties when the transferof harvested adipose tissue is desired: orthopedicsurgery, arthroscopic surgery, neurosurgery,gastrointestinal and affiliated organ surgery,urological surgery, general surgery,gynecological surgery, thoracic surgery,laparoscopic surgery, and plastic and	The Lipogems System is a sterile medical deviceintended for the closed-loop processing oflipoaspirate tissue in medical proceduresinvolving the harvesting, concentrating andtransferring of autologous adipose tissueharvested with a legally marketed lipoplastysystem. The device is intended for use in thefollowing surgical specialties when the transferof harvested adipose tissue is desired: orthopedicsurgery, 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 bodycontouring is desired. Only legally marketedaccessory items, such as syringes, should beused with the system. If harvested fat is to bereimplanted, the harvested fat is only to be usedwithout any additional manipulation.	reconstructive surgery when aesthetic bodycontouring is desired. Only legally marketedaccessory items, such as syringes, should beused with the system. If harvested fat is to betransferred, the harvested fat is only to be usedwithout any additional manipulation.
User Environment	Physician	Physician
Design	Syringe	Canister
Construction	Preassembled	Preassembled
Components	50 mL polycarbonate harvesting and processing syringe unit with vacuum lock and 30 mL output syringe containing a two-stage sieve filter on the inlet Two 30 mL polypropylene luer-lock syringes Three luer caps Luer-to-luer adapter	ABS processing unit containing 5 stainless steel spheres and 2 stainless steel sieve filters Input washing line Access port for loading material Drain Line Access Port for discharge of processed material Bag for collecting waste
Device SizeVariations	50 mL syringe	LGD 60 (60 mL capacity),LGD 240 (240 mL capacity)
Method of Harvesting	Cannula	Cannula
Source of Energy	None - Manual by operator	None - Manual by operator
Device performsHarvesting	Yes - Syringe generated vacuum-lock	No - syringe capable of holding vacuumprovided in kit
Mechanicaloperation	Manual shaking of syringe	Manual shaking of canister (stainless steelspheres)
Device ports	2 ports: load/wash/drain port (combined); outletvalve	4 ports: load valve, wash feeding line, drain line,outlet valve
Tissue WashingMedia	Lactated Ringer's	Physiological saline
Filter/mesh	1000 and 800 micron mesh at outlet – collectedadipose tissue passes though both	2000 micron mesh at inlet and 1000 micronmesh at outlet – collected adipose tissue passesthrough both.
Sterility	Supplied sterile for single use	Supplied sterile for single use
Sterilization Method	Ethylene Oxide	Ethylene Oxide
Sterility AssuranceLevel	SAL = 10-6	SAL = 10-6
Biocompatibility	Biocompatible	Biocompatible

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Performance Testing

The Dermapose 111 Refresh was tested in accordance with established protocols and met the acceptance criteria for all tests performed.

Performance testing included:

Nucleated Cell Viability: Evaluated the nucleated cell viability using a Luna-Stem Automated o Fluorescence Cell Counter.
Tissue Composition: Evaluated the adipose tissue layer after adipose tissue ● was processed using the Dermapose "M Refresh.
System Leak: Evaluated the ability of the Dermapose™ Refresh to hold vacuum (prevent o system leak) via a stationary test and a side load test.
Mechanical Test: Evaluated the mechanical connection testing of the Dermapose™ Refresh. o

Biocompatibility testing for the Dermapose™ Refresh 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
Determination of Extractable Elements per ISO 10993-18:2005
Pyrogen Testing per ISO 10993-11:2017

Sterilization of the Dermapose™ Refresh 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 !14 Refresh 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™ Refresh is substantially equivalent to the predicate device, Lipogems System. The Dermapose™ Refresh has the same indications for use, as well as similar technological characteristics and principles of operation as its predicate device. Thus, the Dermapose™ Refresh is substantially equivalent to the Lipogems System.

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.