The body-jet®, a suction lipoplasty system, is a device intended for aesthetic body contouring. The device consists of a powered vacuum pump (containing an overflow/bacterial filter in the tube between the vacuum pump and suction bag), a collection bag with integrated overflow/bacterial filter, cannulae, and a connecting tube. The suction/collection bags including bacterial filters, the tubing, and the cannulae are to be changed between patients. The powered vacuum pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 26.5 inches of mercury, vacuum control valve to regulate the vacuum with accompanying vacuum gauge, a double piston, and a safety trap. The powered vacuum pump generates a negative pressure for the removal of fat or adipose tissue from distinct body-fat deposits for aesthetic body-contouring.

The body-jet® includes a sterile, single-use tubing set with a small infiltration pump (the WAL Applicator), which transports the saline for the infiltration of the tissue area to be treated, and infiltration and irrigation cannulae. The single-use tubing set (WAL Applicator) and the reusable cannulae have been designed as proprietary products.

AI/ML Overview

The provided document is a 510(k) summary for the "body-jet®" suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices for aesthetic body contouring. The document does not describe acceptance criteria and a study proving the device meets those criteria in the typical format of a diagnostic or AI/machine learning device. Instead, it demonstrates safety and effectiveness through comparisons to existing devices and in-vitro studies.

However, I can extract the relevant information and present it in a structured way that aligns with your request, interpreting "acceptance criteria" as the demonstration of "substantial equivalence" and "performance" as the findings supporting this equivalence for the described device, though it's not a direct match to a standard AI/diagnostic performance study.

Here's an attempt to answer your questions based on the provided document, acknowledging that some fields may not be directly applicable or fully detailed for this type of device submission:

1. Table of acceptance criteria and the reported device performance

For a device like the body-jet®, the "acceptance criteria" are generally based on demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and effectiveness compared to legally marketed predicate devices. The performance data presented are primarily to support these claims.

Acceptance Criteria (Demonstrated Equivalency to Predicate Devices)	Reported Device Performance (Summary of Findings)
Intended Use: Aesthetic body contouring	The body-jet® is intended for aesthetic body contouring, matching the intended use of predicate devices.
Technological Characteristics:	The vacuum pump system, infiltration pump system, and cannulae of the body-jet® are substantially equivalent to those of its predicate devices in terms of intended use, design, operating principles, and materials.
Safety: No damage to vital structures	Histopathological/Immunohistological Performance Data (In-vitro): Two in-vitro laboratory investigations on human fat tissue samples (from corpses and "dead" abdominal fat excisates) showed that the fan-shaped saline spray produces no damage to vital structures such as connective tissue, muscle tissue, blood vessels, and nerves. This supports safety.
Effectiveness: Loosens adipose tissue, separates/aspirates adipocytes	Histopathological/Immunohistological Performance Data (In-vitro): The in-vitro investigations demonstrated that the water-assisted lipoplasty loosens adipose tissue and separates and aspirates adipocytes without damaging vital structures. Clinical Performance Data: Evaluation of published clinical performance data demonstrates that the body-jet® device is as safe, as effective, and performs as well as its predicate devices and other referenced lipoplasty techniques currently cleared for aesthetic body contouring. This supports its effectiveness in achieving aesthetic body contouring.
Overall substantial equivalence	Based on all performance data, the body-jet® is concluded to be substantially equivalent to its predicate devices, and safe and effective for the intended use of aesthetic body contouring.

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:
- In-vitro studies (Histopathological/Immunohistological Performance Data): "Two in-vitro laboratory investigations have been carried out. on fat tissue samples from human corpses (Investigation 1), and from "dead" abdominal fat excisates (Investigation 2)." The specific number of samples or excisates is not provided.
- Clinical Performance Data: This refers to "published clinical performance data," indicating a review of existing literature. The specific number of patients or studies reviewed is not mentioned.
Data Provenance: Not explicitly stated for either the in-vitro studies or the published clinical data. "Human corpses" and "abdominal fat excisates" are mentioned for in-vitro. For clinical data, it's a review of "published" data, suggesting existing studies that could be from various countries and collected retrospectively or prospectively.

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)

The document does not specify the number of experts or their qualifications for evaluating the histopathological slides or for the clinical data review. The analysis summarized in "Section 18" (histopathology) and "Section 20" (clinical) would have been performed by qualified personnel (e.g., pathologists for histopathology, clinicians for clinical data review), but details are absent.

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

This information is not provided in the document. It's unlikely to be applicable in the same way it would be for ground truth establishment in a diagnostic imaging study.

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 MRMC comparative effectiveness study was done. This type of study (human readers with/without AI assistance) is typically relevant for diagnostic AI devices, not for a lipoplasty system.

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

This is not applicable to the body-jet® device, which is a physical medical device (suction lipoplasty system), not an algorithm or AI.

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

For the in-vitro studies: Histopathological analysis and immunohistological performance data on tissue structures (adipose, connective, muscle, blood vessels, nerves). This implies assessment by pathologists.
For the clinical performance: A review of "published clinical performance data" to assess safety and effectiveness. This would involve synthesis of reported outcomes data from existing studies.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or algorithms. The device's design and performance are based on engineering principles and pre-clinical/clinical validation, not on algorithm training.

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

This question is not applicable as there is no training set for this device.

Summary

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Human Med Ag % Tuv Sud America Inc. Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

June 8, 2021

Re: K082025

Trade/Device Name: Body-Jet Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Stefan Preiss:

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 August 13, 2008. 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a staff with a snake entwined around it, which is a symbol of medicine and healing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 1 3 2008

Re: K082025

Trade/Device Name: body-jet® Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MVV Dated: July 28, 2008 Received: July 30, 2008

Dear Stefan Preiss:

We have res iewed 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Stefan Preiss

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliarice at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse ventually (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

KOSTOTE 510(k) Number (if known): body-jet® Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Aesthetic body contouring

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K082018

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

00041 0-0-0-0-0-0

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Section 5 -- 510(k) Summary

K082025 page 1/3

AUG 1 3 2008

This 510(k) Summary for body-jet® meets the requirements of 21 CFR § 807.92

1. Submitter Information

Human Med AG Wilhelm-Hennemann-Strasse 9 D-19061 Schwerin Germany

Contact Person:

Inge Matthiesen c/o Human Med AG Wilhelm-Hennemann-Strasse 9 D-19061 Schwerin Germany

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

1. Name of Device:

Common name:	Suction Lipoplasty System
Proprietary name:	body-jet®
Classification:	Suction Lipoplasty System, Class II, 21 CFR § 878.5040
Product code:	MUU
Indications for use:	Aesthetic body contouring

3. Name of the predicate device(s)

Liposat® Power Infiltration Pump (Model 00002274) . Moeller Medical GmbH & Co. KG (K053451)
Dominant 50 Lipo Powered Suction Pump, . Medela AG (K063336)
Byron Medical Infiltration and Aspiration Cannulae and Needles . Byron Medical, Inc. (K981172)

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K082025 Page 2/3

4. Device Description

5. Indications for Use

The body-jet® is intended for aesthetic body contouring.

6. Summary of Technological Characteristics

The body-jet® vacuum pump system consists of a powered vacuum pump with two WOB-L pistons (dynamic compression by fixed piston inside cylinder) working bit-parallel in the punp. The powered vacuum pump generates a negative pressure for the removal of adipose tissue. Two suction containers of identical design and mode of operation, one on the left side and one on the right side of the body-jet® device, are provided for holding the suction bags.

The suction bags are equipped with a dual-function filter acts simultaneously as an overflow protection and a bacterial barrier and closes automatically when it contact with fluids. The connecting tube between the collection bag and the vacuum pump contains an overflow protection/bacterial filter. It is used when the dual filter in the suction bag is damaged. If the fluid reaches a maximum level in the bag, the floats in the overflow filter will block the inlet port, automatically stopping the suction. This prevents the back-up of fluid to either the pump or the patient. The tubing is able to withstand the amount of negative pressure created by the vacuum pump without collapsing.

A small infiltration pump (included in the single-use WAL Applicator) transports the saline for the infiltration of the treated tissue area via the infiltration cannulae, similar to the procedure of traditional liposuction and of its predicate devices. The WAL Applicator has been designed as a single-use proprietary product. The cannulae are re-sterilizable proprietary products.

The vacuum pump system, the infiltration pump system and the cannulae of the body-jet® are substantially equivalent to the vacuum and infiltration pump systems, and the cannulae of its predicate devices in terms of intended use, design, operating principles, and materials.

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K082025 page 3/3

7. Summary of Histopathological and Immunohistological Performance Data

In order to support a determination of safety and effectiveness, the effect of the fan-shaped saline spray of the body-jet® has been studied on different human tissue structures. For this purpose two in-vitro laboratory investigations have been carried out. on fat tissue samples from human corpses (Investigation 1), and from "dead" abdominal fat excisates (Investigation 2). No humans have been treated for the purpose of these in-vitro laboratory investigations.

The following tissue structures were examined: :

. adipose tissue,
connective tissue, �
muscle tissue, .
. blood vessels.
nerves. .

Based on the results of these investigations (please refer to Section 18) it can be summarized that water assisted lipoplasty with the fan-shaped water spray of the body-jet" produces no damage to vital structures like connective tissue, muscle tissue, blood vessels and nerves, thus supporting a determination of safety and substantial equivalence of the body-jet® water-assisted technique WAL to its predicate devices and the other referenced lipoplasty techniques.

8. Summary of Clinical Performance Data

The evaluation of published clinical performance data demonstrate that the body-jet" device is as safe, as effective, and performs as well as its predicate devices and the other referenced lipoplasty techniques that are currently cleared for aesthetic body contouring.

Based on the results of the published clinical performance data (as presented in Section 20) and the pathohistological performance data (as presented in Section 18) it can be summarized that water assisted lipoplasty with the fan-shaped water spray of the body-jet® loosens the adipose tissue, and separates and aspirates the adipocytes without producing any damage to vital structures like connective tissue, muscle tissue, blood vessels and nerves, thus supporting a determination of safety and effectiveness, and substantial equivalence of the body-jef waterassisted technique (WAL) to its predicate devices and the other referenced lipoplasty techniques.

9. Conclusion

Based upon the information presented above and in this 510(k) submission , it is concluded that the proposed body-jet® is substantially equivalent to its predicate devices, and safe and effective for the intended use of aesthetic body contouring.

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.