The Automatic Tissue Processing Unit is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The Automatic Tissue Processing Unit is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Automatic Tissue Processing Unit is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

Neurosurgery Gastrointestinal Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Arthoscopic Surgery

Device Description

The fat harvested by liposuction, called as lipoaspirates, contains fat tissues, bloody impurities and tumescent solution. The harvested lipoaspirates are not appropriate for autologous fat transfer without removal of the bloody impurities and tumescent solution containing anesthetic agent, anti-coagulant agent, antibiotics etc. In addition, the harvested fat tissues are not homogenous and contain uneven fibrotic tissues. So, for the purpose of in autologous fat transfer surgical technique. ACPU kit is designed and developed for harvest of the fine homologous adipose tissue in a sterile and closed way. ACPU needs to be centrifuged by using exclusive centrifuge (ACS Combo-A-Centrifuge/Product code: JQC) and the kits are single-use only.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the Automatic Tissue Processing Unit, structuring the information according to your requested points:

Device: Automatic Tissue Processing Unit (ACPU-100/ACPU-200)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful results of the specified tests, indicating that the device meets predetermined standards for each parameter. The "Requirements" column serves as the acceptance criteria.

Test Item	Acceptance Criteria (Requirements)	Reported Device Performance (Results)
Appearance	No defects, flaws, breakage, or contamination of foreign objects.	Pass
Measurement	Within ±5% of stated dimensions.	Pass
Leakage	No leakage.	Pass
Residuals of cleaning liquid	Less than 20 ml.	Pass
Packaging	Adhesive strength not less than 3N (ASTM F-88).	Pass
Nucleated Cell Count	More than 3.86x10^5 per ml of adipose tissue.	"3.86 over" - Implies greater than or equal to, thus meeting the criteria.
Nucleated Cell Viability	More than 71.4%.	"71.4% over" - Implies greater than or equal to, thus meeting the criteria.
Extraction test:
Appearance (sample prep extract)	No foreign material.	Pass
pH (Difference)	≤ 1.5	Pass
KMnO4 Reducing agents (Difference in titres)	≤ 2.0 ml	Pass
Evaporating residue (Difference in extractables)	≤ 1.0 mg	Pass
Heavy metal (as Pb)	Not darker than standard solution.	Pass
UV-vis Spectrum (Difference in absorbance 250nm-350nm)	≤ 0.1	Pass
Biocompatibility Tests:
Cytotoxicity (ISO 10993-5)	Pass (implicitly defined by standard)	Pass
Skin Sensitization (ISO 10993-10)	Pass (implicitly defined by standard)	Pass
Intracutaneous Reactivity Test (ISO 10993-10)	Pass (implicitly defined by standard)	Pass
Acute Systemic Toxicity Test (ISO 10993-11)	Pass (implicitly defined by standard)	Pass
Pyrogen Test (ISO 10993-11, Annex F)	Pass (implicitly defined by standard)	Pass
Hemolysis Test (ISO 10993-4)	Pass (implicitly defined by standard)	Pass

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

The document does not explicitly state the sample size for the "bench tests." The tests listed are primarily physical, chemical, and biological characterization tests performed on the device itself or its materials, rather than a clinical human subject test set. The data provenance is not specified, but these are laboratory tests rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since the tests performed are bench tests (biocompatibility, mechanical, sterility, extraction, cell counts/viability), the concept of "ground truth" established by human experts in a diagnostic or clinical context is not applicable. The ground truth for these tests is based on objective laboratory measurements and established scientific standards (e.g., ISO guidelines, ASTM standards, chemical analysis techniques).

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where human interpretation of medical images or outcomes needs consensus. For the bench tests described, adjudication is not applicable. The "results" are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document describes bench testing to demonstrate functionality and substantial equivalence to a predicate device, not a human reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an Automatic Tissue Processing Unit, a mechanical/biological processing system, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance data in this submission consists of:

Objective physical measurements: Dimensions, leakage, adhesive strength.
Chemical analysis results: Residuals of cleaning liquid, pH, KMnO4 reducing agents, evaporating residue, heavy metals, UV-vis spectrum.
Biological assay results: Nucleated cell count and viability.
Standardized biological test outcomes: Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis) performed according to ISO standards, where "Pass" is the objective outcome based on the standard's criteria.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The data presented is for validation and verification of the physical device's performance.

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

Not applicable, as there is no training set for this type of device.

Summary

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May 25, 2018

BSL Co. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K172717

Trade/Device Name: Automatic Tissue Processing Unit Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: April 25, 2018 Received: April 25, 2018

Dear Mr. Chung:

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172717

Device Name Automatic Tissue Processing Unit

Indications for Use (Describe)

Neurosurgery Gastrointestinal Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Arthoscopic Surgery
Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k)Summary [as required by 807.92(c)]

1Applicant

1. Company: BSLCo.
Address: 6-13, Chilsan-ro 237beon-gil,Gimhae-si,Gyungsangnam-do, South Korea য
Tel:82-55-328-9235 3)
1. Fax:82-55-328-9236
Prepared date: July 4, 2017 5)
1. Contact person: Peter Chung,412-512-8802
Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA 7)
1. Submission date: August 25, 2017

2. Device Information

1. Trade name: Automatic Tissue Processing Unit
2 Common name: Fat Concentration System
3 Regulation name: Suction Lipoplasty System
4 Product code: MUU
1. Regulation number: 878.5040
റ്റം Class of device: Class II
1. Panel: General and Plastic surgery
1. The legally marketed device to which we are claiming equivalence K121005, AdiPrep™Adipose Transfer System

4. Device description

5. Intended Use:

The Automatic Tissue Processing Unit is used in medical procedures involvingthe harvesting and transferring of autologous adipose tissue. The Automatic Tissue Processing Unit is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Automatic Tissue Processing Unit is intended for

use in the following surgical specialties when the concentration of harvested adipose tissue is desired.

Neurosurgery
Gastrointestinal Surgery
Urological Surgery
-Plastic and Reconstructive Surgery
-General surgery
Orthopedic Surgery
Gynecological Surgery
Thoracic Surgery
Laparoscopic Surgery
Arthroscopic Surgery

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6. Performance data:

1. Bench test were performed. Bench testing included biocompatibility, mechanical testing,sterility testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

Test item	Requirements	Results
Appearance	Itshould not be defects inflaws, breakage or contamination of foreign objects.
Measurement	When measuring with Vernier calipers, according to the dimension of 'shape and structure' part, the stated should be within ±5 %.
Leakage	When tested according to the test method, there should be no leakage.
Residuals of cleaning liquid	When tested accordingto the test method, the residuals of cleaning liquid should be less than 20 ml.	Pass
Packaging	Adhesive strength shall be tested by ASTM F-88 to be not less than 3N
Nucleated Cell Count	Nucleated cells should have more than 3.86x105 per ml of adipose tissue
Nucleated Cell Viability	Viability of nucleated cells should be more than 71.4%
Extraction test
Appearance	When observe sample preparation extract with naked eyes, there should not be foreign material.
pH	Difference in pH S: 1.5
KMn04 Reducing agents	Difference intitres S: 2.0 ml	Pass
Evaporating residue	Difference in extractables S 1.0 mg
Heavy metal (as Pb)	Not darker than standard solution.
UV-vis Spectrum	Difference inabsorbance (250nm-350nm) S:0.1

2Biocompatibility

#	Testitem	Test method /Test criteria	Test result
1	Cytotoxicity	ISO 10993-5 Tests for in vitro cytotoxicity	Pass
2	Skin SensitizationTest	ISO 10993-10 irritation and skin sensitization	Pass
3	IntracutaneousReactivity Test	ISO 10993-10 Test for irritation and skin sensitization, maximization testfor delayed hypersensitivity	Pass
4	Acute SystemicToxicity Test	ISO 10993-11 Test for systemic toxicity -Acute Systemic Toxicity	Pass
5	Pyrogen Test	ISO 10993-11Tests for systemic toxicity, Annex(F) Information onmaterial-mediated pyrogens.	Pass
6	Hemolysis Test	ISO 10993-4 Selection of tests for interactions with blood	Pass

The performance tests demonstrated that Automatic Tissue Processing Unit performs ina substantially equivalent manner to the predicate device.

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7.ComparisonTable of ACPU-100/AC PU-200

Manufacturer	BSL Co.	AdiprepTM	Remark
SIO(K) No.		K121005	N/A
Indication foruse	The Automatic Tissue Processing Unit is used inmedical procedures involving the harvesting andtransferring of autologous adipose tissue. TheAutomatic Tissue Processing Unit is used forconcentrating adipose tissue harvested with alegally marketed lipoplasty system.TheAutomatic Tissue Processing Unit is intended foruse in the following surgical specialties when theconcentration of harvested adipose tissue isdesired.* Neurosurgery* Gastrointestinal Surgery* Urological Surgery* Plastic and Reconstructive Surgery* General surgery* Orthopedic Surgery* Gynecological Surgery* Thoracic Surgery* aparoscopic Surgery* Arthroscopic Surgery	The AdiPrep™ Adipose Transfer System isusedin medical procedures involving the harvestingand transferring of autologous adipose tissue.The Adiprep system is used for concentratingadipose tissue harvested with a legallymarketed lipoplasty system. AdiPrepTM AdiposeTransfer system is intended for use in thefollowing surgical specialties when theconcentration of harvested adipose tissue isdesired .* Neurosurgery* Gastrointestinal Surgery* Urological Surgery* Plastic and Reconstructive Surgery* Generalsurgery* Orthopedic Surgery* Gynecological Surgery* Thoracic Surgery* Laparoscopic Surgery* Arthroscopic Surgery	Same
Model/type	ACPU-100/ACPU-200	ADI-25-01 AdiPrep Procedure pack	N/A
Appearance	Image: ACPU-100/ACPU-200	Image: ADI-25-01 AdiPrep Procedure pack	Different
ProcessingPack:Materials	ACPU-100 kit / ACPU-200 kit	Components - Syringes with removableplunger, centrifuge tubes with filter, aspiration& fat injection cannula,fat injection syringes,skin puncture needles, and oil extractionsyringe & needle. Cannula & syringescomposed of medicalgrade plastics.	Different
Fill volumes	5 to 25ml	5 to 25ml	same
SterilizationMethod	Ethylene-OxideGas(EtO)	Ethylene-Oxide Gas (EtO)	same
Autologous Adipose Product
Nucleated cellcount (x105 mlof product)	3.86 over	Mean 1.848	Similar
Nucleated cellviability	71.4% over	Mean 83.5	Similar
Processing capabilities
Volume	5 to SOml	Sta 25ml	Similar
Low-g-force	Centrifuge to spin for approximately 4 minutes at1250 g-force (ACPU-200 kit)Centrifuge to spin for approximately 5 minutes at375 g-force (ACPU-100 kit)	Centrifuge to spin for approximately 4 minutesat 1250 g-force	Sameanddifferent
Laboratorycentrifuge	ACS Combo-A CentrifugeCENTRIFUGES (MICRO, ULTRA, REFRIGERATED)FOR CLINICAL USE or laboratory centrifuge forclinical use	SmartPReP2 centrifuge isa general-purposelaboratory centrifuge for clinical use	N/A

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Conclusion

The device is investigated for function and effectiveness to compare the operation of function between proposed device and predicate device (K121005). Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device. Therefore, it is concluded that is Automatic Tissue Processing Unit of BSL Co. substantially equivalent to the legally marketed predicate device.

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.