The LipoCollector II complete set consists of an autoclavable polymeric tissue collection container with a stainless steel lid and pre-fillering basket, and a disposable set including mesh filters. O-rings and inner tubing. The LipoCollector II complete set also includes a stainless steel extraction cannula (single-use) for withdrawal of the collection container. From the extraction cannula, the fat can be directly transferred to a Luer-Locksyringe (not part of the LipoCollector !! complete set) for autologous fat transfer. The intended use of the LipoCollector II complete set is to filter and collect the aspirated fat tissue for subsequent transfer of the autologous fat into subcutaneous fat tissues during the same procedure.

AI/ML Overview

The provided text describes the LipoCollector II complete set, a device for harvesting, filtering, and transferring autologous fat tissue. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards rather than presenting a study to prove performance against specific acceptance criteria for a novel algorithm or diagnostic output.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific metric for fat viability/purity). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices. The "acceptance criteria" discussed are related to design specifications, product function, safety, instructions for use, packaging, and risk management, which are general quality system requirements rather than specific performance metrics.

Acceptance Criteria (Type)	Reported Device Performance/Compliance
Product Function, Safety, Instructions for Use, Packaging	"Acceptance criteria for verification and validation testing of the device are based upon the approved product design specifications, including any additional design requirements imposed by Risk Management Process. Acceptance criteria for the LipoCollector II complete set include factors addressing product function, product safety, instructions for use, and packaging. All requirements of ISO 14971:2007 were met." (General statement of compliance)
Biocompatibility	- Cytotoxicity test (EN ISO 10993-5): No cytotoxic effects found. - Irritation and delayed-type hypersensitivity (EN ISO 10993-10): No negative effects observed in an epicutaneous test with 10 volunteers. - Endotoxin detection (EN ISO 10993-11): No endotoxins detected (LAL-Test). -> Device considered biocompatible for intended use.
Sterilization (ETO)	- Validated by physical and microbiological methods (ISO 11135-1:2007). - Sterilization safety level of 10^-6 guaranteed. - ETO residuals comply with ISO 10993-7.
Sterile Packaging	- Validated in accordance with ISO 11607-1, 11607-2, DIN 58953, EN 868-5. - Packaging is impervious to microorganisms.
Reprocessing (Reusable Parts)	- Reprocessing of reusable parts successfully validated according to AAMI/ANSI ST81:2004.
Quality Management System	- Implemented in accordance with DIN EN ISO 13485 and Council Directive 93/42/EEC.
Design and Manufacturing Controls	- In accordance with DIN EN ISO 13485 (Section 7.3) and 21 CFR 820.30. - Complies with DIN EN ISO 10079-1:2009, CSA Z 168.11-94, ISO 2768-1:1989, ISO 2768-2:1989, ISO 7153-1:1991/Amd.1:1999, and ISO 9626:1991/Amd.1:2001.
Labeling	- Complies with ISO 15223-1, FDA 21 CFR 801.1, and Canadian MDR labeling guidance.
Risk Management	- All requirements of ISO 14971:2007 were met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For the biocompatibility test (Irritation and delayed-type hypersensitivity - Epicutane test), 10 volunteers were used.
- For other tests (cytotoxicity, endotoxin, sterilization, packaging, reprocessing), the "sample size" refers to tested components/devices, but specific numbers are not provided beyond the general statement that tests were conducted according to standards. The document doesn't define a "test set" in the context of device performance in humans or on clinical data, as it's not an AI/diagnostic device.
Data Provenance: Not explicitly stated for all tests. For the epicutaneous test, it's a prospective human study. For other tests, they are laboratory-based, not clinical data provenance. The company is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is not an AI/diagnostic system requiring expert readers for ground truth establishment on a performance evaluation test set. The "ground truth" for compliance testing is defined by the standards themselves (e.g., cytotoxicity present/absent, sterility achieved/not achieved).

4. Adjudication Method for the Test Set

This information is not applicable as there is no diagnostic output or interpretation by experts requiring adjudication for a test set.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical tool for fat processing, not an AI diagnostic assistant tool for human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" used for this device's validation is primarily defined by:

Standard Compliance: Adherence to defined parameters and methodologies outlined in recognized international and national standards (e.g., ISO, EN, AAMI/ANSI, CFR).
Laboratory Test Results: Factual outcomes from specific biocompatibility (cytotoxicity, endotoxin, irritation), sterilization, and packaging tests.
Design Specifications: The device's ability to meet its pre-defined design and functional requirements.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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K101713 page 1/6

510(k) Summary LipoCollector II complete set

This 510(k) Summary for the LipoCollector II complete set meets the requirements of 21 CFR § 807.92

Date: 2010-05-28

JUN 2 9 2010

1. Submitter Information

human med AG Wilheim-Hennemann-Straße 9 D-19061 Schwerin Germany

Contact Person:

Dr. Inge Matthiesen c/o human med AG Wilhelm-Hennemann-Straße 9 D-19061 Schwerin Germany

Phone: +49(0)385 395 70 0 +49(0)385 395 70 29 Fax:

2. Name of Device:

Common Name:	Suction Lipoplasty System
Proprietary Name:	LipoCollector II complete set
Classification:	Class II - 21 CFR § 878.5040
Product Code:	MUU
Indications for use:	Aesthetic body contouring
ntended use:	Harvesting, filtering and transferring of autologous fat tissue,

3. Name of predicate device(s)

Cytori AFT System; Cytori Therapeutics Inc Product Code MUU; 510(k) . number K072587
Lipokit; Medi-Khan (USA) Inc Product Code MUU; 510(k) number K083455 .
Lipivage; Genesis Biosystems, Inc. 510(k) number unknown ●

つ

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4. Description of the new device

The LipoCollector II complete set is used together with FDA cleared devices (such as vaccuum devices, tubings, and syringes), for example suction lipoplasty devices (Product Code MUU, Regulation Number 21 CFR 878.5040), and syringes (e.g. 50 cc syringes, Luer-Lock, Product Code KYX). The aspirated fat gets transferred from the aspiration device to the collection container by the application of vacuum. The vacuum is generated by the aspiration device (e.g. suction lipoplasty device).

The LipoCollector il complete set serves to filter fatty and adherent tissue from the aspirate which is extracted during liposuction. The separated water (saline) gets transferred to the waste container of the aspiration device via a tube by the application of vacuum which is generated by the aspiration device. From the LipoCollector II collection container, the harvested fat is being removed by the extraction cannula, and then transferred into a syringe for autologous fat transfer into the desired body area(s).

The filtering of the aspirate with the LipoCollector II complete set is done predominantly using buovancy and gravity. A special filter unit, comprising a stainless steel wire fabric with a mesh/hole size from 200 um to 315 um, captures the appropriate fat particles in a sterile collection container in such a way that only the saline rinsing solution ends up in the suction (waste) container provided. All parts are sterile and air contact to the fat from outside is avoided due to the closed system design of the LipoCollector II.

Function principles

The filtering of the aspirate with the LipoCollector II complete set is done predominantly using buoyancy and gravity. The suction of the liposuction system bypasses the previously collected aspirate via the integrated bypass. This means that the fatty tissue that has been suctioned off is handled as gently as possible.

The main principle behind the function of the LipoCollector II complete set is the initial separation of liguid and lipocytes due to the physical buoyancy. The less dense fat floats on the liquid which is concurrently and continuously suctioned off. In doing so the filter is constantly rinsed with liquid which reduces blockage of the filter mesh.

The LipoCollector II complete set is equipped with a stainless steel basket that acts as a prefilter. By turning the lid of the LipoCollector II, the basket is positioned precisely beneath the opening of the connection labelled PATIENT, ensuring that incoming aspirate first runs through the basket. Larger strands of connective tissue are retained in the grates of the basket, which reduces blockage of the mesh filter and/or cannula.

Mesh filters: Three sizes of mesh filters are supplied with the LipoCollector II (200 µm, 250 µm and 315 um).

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K101713

page 3/6

Closed system filtration

The LipoCollector II complete set which is to be used under sterile conditions in the operating room represents a closed system. The LipoCollector II remains in a sterile field at all times. thus reducing the risk of infection. Also, the risk of contamination is lowered because the fat never leaves the closed sterile LipoCollection container until re-injection.

Using the LipoCollector II complete set decreases the number of steps a physician must take to process the fat for autologous fat transfer (e.g. there are no extra steps of transferring the harvested fat between different containers or of subsequent centrifugation required). The LipoCollector II complete set allows collection and filtering in one step in one closed system container, and thereby maintaines the sterility of the harvested fat until the fat is transferred .

Extraction cannula of the LipoCollector II

The included sterile extraction cannula is used to withdraw the harvested fat from the LipoCollector II. The filtered aspirate is withdrawn from the collection container by the extraction cannula while keeping the lid of the LipoCollector II closed.

5. Intended Use

The intended use of the LipoCollector II is the harvesting, filtering and transferring of autologous fat tissue.

6. Summary of technological characteristics of the new device in comparison to those of the predicate devices

The LipoCollector II complete set shares indications, intended use and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to premarket devices: Cytori AFT System (K072587), Lipokit (K083455) and Genesis Biosystems Lipivage (510(k) number unknown).

The LipoCollector II complete set and the predicate devices are substantially equivalent with respect to their indication for use and their intended use, as they are all intended for the same procedure of harvesting, filtering and transferring of autologous fat tissue.

Design and Materials

The design and materials of the LipoCollector II complete set and the predicate devices (Cytori AFT System (K072587), Lipokit (K083455) and Genesis Biosystems Lipivage (510(k) number unknown)) are substantially equivalent, as they share the major design principles of utilizing vacuum (liposuction devices or house vacuum) to aspirate adipose tissue from the patient and subsequently transport the adjpose tissue through a tube into a collection container that contains a filtering mechanism to allow fluids to pass, but retains the adipose tissue within the container.

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K101713 page 4/6

In summary, the design and materials of the LipoCollector II complete set and its predicate devices (Cytori AFT System (K072587), Lipokit (K083455) and Genesis Biosystems Lipivage (510(k) number unknown)) are substantially equivalent, as they are all polymer constructed with surgical stainless steel components for direct patient contact, with collection containers which are operated manually, and utilizing varying sources of vacuum to withdraw and collect saline fluids containing fat tissue, from the body.

The LipoCollector II complete set is substantially equivalent to the above mentioned predicate devices, as they all consist of a polymeric tissue collection container with a filter unit within the chamber, and all have connection ports on the superior ends of the collection container for the attachment of suction tubing, and stainless steel cannulae that contact the patient, and connection ports to connect the vacuum tubing that draws vacuum and carries waste to the waste container.

Like the above mentioned predicate devices, the LipoCollector II complete set decreases the number of steps a physician must take to process the fat for autologous fat transfer. When using the LipoCollector II complete set the fat remains in the sterile container at all times until immediately before reinjection, thus reducing the risk of contamination. The LipoCollector II complete set allows collection and filtering in one step in one collector.

7. Summary of compliance tests according to recognized standards

Design and Manufacturing Process Control Activities

human med AG has implemented a Quality Management System in accordance to DIN EN ISO 13485 and to the Council Directive 93/42/EEC on medical devices.

All design and manufacturing control activities for the LipoCollector II complete set are in accordance to section 7.3 of DIN EN ISO 13485 and to the Code of Federal Regulations (CFR) Title 21, Section 820.30.

The design and manufacturing activities of the LipoCollector II complete set all comply with the requirements of DIN EN ISO 10079-1:2009. CSA Z 168.11-94. ISO 2768-1:1989, ISO 2768-2:1989, ISO 7153-1:1991/Amd.1:1999 and ISO 9626:1991/Amd.1:2001.

For product labeling of the LipoCollector II complete set the requirements according to ISO 15223-1 are applied. The requlations of FDA 21 CFR 801.1. Device Labeling Guidance, and the Guidance for Labeling of the Canadian MDR were examined for special requirements regarding product labeling and product information.

Acceptance criteria for verification and validation testing of the device are based upon the approved product design specifications, including any additional design requirements imposed by Risk Management Process. Acceptance criteria for the LipoCollector II complete set include factors addressing product function, product safety, instructions for use, and packaging. All requirements of ISO 14971:2007 were met.

Biocompatibility Testing

Biocompatibility of the LipoCollector II complete set was examined for patient contact materials. The evaluation of the scope of biological testing was carried out as per EN ISO 10993-1:2009.

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The intended use of the LipoCollector II complete set involves contact with tissue and bodily fluids for a period of less than 24 hours. To evaluate the biocompatibility of the LipoCollector II complete set, the following tests were necessary:

KI01713

Cytotoxicity test as per EN ISO 10993-5:2009-10, Annex C(metabolic cell activity)
Cytotoxicity test as per EN ISO 10993-5 (membrane integrity)
Epicutane test as per EN ISO 10993-10:2002-09,
Quantitative detection of endotoxine in liquids and eluates as per EN ISO 10993-11:2006-08
In vitro pyrogen test (IPT) as per EN ISO 10993-11:2006-08.

Results of the biological testings according to 10993-10 and 10993-11

Using the test material as mentioned before no cytotoxic effects could be found. The tests for irritation and delayed-type hypersensitivity according to the DIN EN ISO 10993-10. 2002 were performed with an epicutane test with 10 volunteers. No neaative effects were observed. Also, with the LAL-Test (Limulus - Amebocyte - Test) no endotoxine could be detected in the eluate of the product.

Based on the submitted biocompatibility documentation, the LipoCollector II complete set can be regarded as biocompatible for the intended use of harvesting, filtering and transferring of autologous fat tissue.

Validation of ETO Sterilisation Cycle

The disposable products of LipoCollector II complete set are ETO sterilized by a CE and FDA registered contract sterilisation company. The sterilisation procedure to be used has been successfully validated by physical and microbiological methods in accordance to ISO 11135-1:2007. The evaluation reveals that the single-use products of the LipoCollector II collection container and the extraction cannula sterilized with the validated cycle and a sufficient sterilization safety level of 10° is guaranteed. The single-use products of the LipoCollector II complete set were evaluated for compliance with ISO 10993-7 for ETO residuals. The test results demonstrate compliance with the specifications.

Validation of Sterile Packaging

Packaging for the disposable products of the LiboCollector II complete set was successfully validated, and is compatible with the ETO sterilisation method. The packaging was qualified by testing to assure imperviousness to micro organisms. The validation of sterile packaging is in accordance to ISO 11607-1, 11607-2, DIN 58953 and EN 868-5.

Validation of Reprocessing

The reprocessing of the reusable parts of the LipoCollector II complete set (e.g. collection container, stainless steel lid and basket) has been successfully validated according to the requirements of AAMI/ANSI ST81:2004 "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices".

8. Conclusions

Based upon the intended use, materials, and technological characteristics as presented in this notification, the subject device is shown to be substantially equivalent to the currently marketed predicate devices. There are no significant differences between the LipoCollector II complete set and its predicate devices relevant for safety and effectiveness with respect to the intended use of harvesting, filtering and transferring of autologous fat tissue

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K101703 page 6/6

The intended use, the design, the materials and the collection principle of the LipoCollector II complete set are considered as substantially equivalent to its predicate devices (Cytori AFT System (K072587), Lipokit (K083455) and Genesis Biosystems Lipivage (510(K) number unknown)).

Also, the documentation for the LipoCollector II complete set on biocompatibility testing, sterilisation and further compliance testing according to recognized standards, as submitted in this 510(k) application, demonstrate that the LipoCollector II complete set can be regarded as safe and effective for the intended use of harvesting, filtering and transferring of autologous fat tissue.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines forming the wings and body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 9 2010

Human Med AG % TUV SUD America Inc. Mr. Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

Re: K101713

Trade/Device Name: LipoCollector II Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: June 11, 2010 Received: June 18, 2010

Dear Mr. Preiss:

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. 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

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Page 2 - Mr. Stefan Preiss

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

erely yours,

N. Melkerson

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K101713

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

: 上一篇:

Aesthetic body contouring

Intended Use:

Harvesting, filtering and transferring of autologous fat tissue

Prescription Use(Part 21 CFR 801 Subpart D)	yes		Over-the-Counter Use(21 CFR 801 Subpart C)	no
-------------------------------------------------	-----	--	------------------------------------------------	----

AND/OR

David Krone for MXM

(Division Sign-Off)

Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number	K101713
---------------	---------

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.