K Number
K200168
Device Name
Dermapose Access
Manufacturer
Date Cleared
2020-04-22

(90 days)

Product Code
Regulation Number
878.5040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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: - 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.
More Information

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.

No.
The device is intended for aesthetic body contouring through fat harvesting, which is not a therapeutic medical purpose.

No
Explanation: The device description states its purpose is to "assist the harvesting of autologous fat from a patient" for body contouring, which is a therapeutic/surgical procedure, not a diagnostic one. It does not mention any function for diagnosing conditions.

No

The device description clearly outlines physical components such as a polycarbonate housing, needle, cannula, and tubing, indicating it is a hardware-based medical device.

Based on the provided information, the Dermapose™ Access is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is "aesthetic body contouring" and "harvesting of autologous fat from a patient". This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
  • Device Description: The device is designed to assist in the physical process of harvesting fat tissue from a living patient. It involves creating an incision, introducing a cannula, and using vacuum to extract tissue. This is a procedural device, not a diagnostic one.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) for diagnostic purposes. The device's function is purely mechanical and procedural.
  • Performance Studies: The performance studies focus on the device's ability to perform the fat harvesting procedure (skin puncture, reliability, skin hold, cannula performance) and its biocompatibility and sterility. These are typical performance metrics for surgical or procedural devices, not IVDs.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Dermapose™ Access does not fit this definition.

N/A

Intended Use / Indications for Use

The Dermapose Access fat harvest system is intended for use in aesthetic body contouring.

Product codes

QPB, MUU

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:

  • 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
    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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

§ 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.

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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

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,

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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 LLC
420 Stevens Avenue, Suite 220
Solana Beach, CA 92075 USA |
|------------------|-----------------------------------------------------------------------------------------------------------|
| Company Contact: | Olivia Kim
RA/QA Director
Phone: (858) 386-4140
Fax: (858) 217-5134
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
Dermapose™ Access | Predicate Device
St'rim (K142073) | Similarity |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The Dermapose™ Access fat harvest
system is intended for use in aesthetic
body contouring. | The st'rim™ fat tissue harvest and
injection cannula set is intended for
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
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
Energy | None - Manual by operator | None - Manual by operator | Identical |
| Source of Skin
Hold Energy | User provided vacuum source | None - Manual by operator (pinch) | Different |
| Device performs
Harvesting | No – requires syringe capable of
holding vacuum | No - requires syringe capable of
holding vacuum | Identical |

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| Mechanical
operation (entry) | Needle incision followed by
concentric cannula introduction, then
needle removal | Needle incision, then needle removal,
followed by cannula introduction | Similar |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------|
| Mechanical
operation
(harvest) | Requires syringe capable of holding
vacuum, motion is back and forth and
sweeping about entry point | Requires syringe capable of holding
vacuum, motion is back and forth and
sweeping about entry point | Identical |
| Mechanical
operation
(process) | Not part of system | Not part of system | Identical |
| Mechanical
operation
(delivery) | Injection via small syringes and
injection cannula (not included) | Injection via small syringes (not
included) and injection cannula
(included) | Similar |
| Construction | Preassembled except for luer
connections | Preassembled except for luer
connections | Identical |
| Sterility | Supplied sterile for single use | Supplied sterile for single use | Identical |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterility
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