(132 days)
Not Found
No
The device description and performance studies focus on mechanical and biological properties, with no mention of AI or ML.
No
The device is described as a system for harvesting, concentrating, and transferring autologous adipose tissue, not for directly treating a disease or condition.
No
The device is described as a sterile medical device for the closed-loop processing, harvesting, concentrating, and transferring of autologous adipose tissue, not for diagnosis.
No
The device description clearly outlines physical components like syringes, filters, and a stand, indicating it is a hardware-based medical device for processing tissue.
Based on the provided information, the Dermapose Refresh is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating of autologous adipose tissue". This describes a surgical procedure involving tissue manipulation within the body or for re-implantation, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a syringe system for harvesting, concentrating, and transferring fat tissue. This aligns with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze a sample to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the device's mechanical integrity, biocompatibility, and the viability and composition of the processed tissue. These are relevant to a surgical device, not an IVD.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Dermapose Refresh's function is to process and prepare tissue for re-implantation, which falls under the category of a surgical or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MUU
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™ Refresh Stand.
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:
- Nucleated Cell Viability: Evaluated the nucleated cell viability using a Luna-Stem Automated Fluorescence Cell Counter.
- Tissue Composition: Evaluated the adipose tissue layer after adipose tissue was processed using the Dermapose™ Refresh.
- System Leak: Evaluated the ability of the Dermapose™ Refresh to hold vacuum (prevent system leak) via a stationary test and a side load test.
- Mechanical Test: Evaluated the mechanical connection testing of the Dermapose™ Refresh.
Biocompatibility testing for the Dermapose™ Refresh 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.
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 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
1
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
2
Indications for Use
510(k) Number (if known) K193363
Device Name Dermapose Refresh
Indications for Use (Describe)
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
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: 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:
-
- 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.
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 Device
Dermapose™ Refresh | Predicate Device
Lipogems System (K171135) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Dermapose™ 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, thoracic surgery,
laparoscopic surgery, and plastic and | The Lipogems System 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, 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
reimplanted, the harvested fat is only to be used
without any additional manipulation. | 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. |
| 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 Size
Variations | 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 performs
Harvesting | Yes - Syringe generated vacuum-lock | No - syringe capable of holding vacuum
provided in kit |
| Mechanical
operation | Manual shaking of syringe | Manual shaking of canister (stainless steel
spheres) |
| Device ports | 2 ports: load/wash/drain port (combined); outlet
valve | 4 ports: load valve, wash feeding line, drain line,
outlet valve |
| Tissue Washing
Media | Lactated Ringer's | Physiological saline |
| Filter/mesh | 1000 and 800 micron mesh at outlet – collected
adipose tissue passes though both | 2000 micron mesh at inlet and 1000 micron
mesh at outlet – collected adipose tissue passes
through both. |
| Sterility | Supplied sterile for single use | Supplied sterile for single use |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Sterility Assurance
Level | 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