(259 days)
Not Found
No
The description focuses on mechanical processing (centrifugation) of adipose tissue and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device processes tissue for use in medical procedures but does not directly treat a disease or condition.
No
The device is an Automatic Tissue Processing Unit used for concentrating autologous adipose tissue by removing impurities and preparing it for transfer. Its function is to process tissue, not to diagnose a medical condition or disease.
No
The device description explicitly mentions a "ACPU kit" and the need to be "centrifuged by using exclusive centrifuge (ACS Combo-A-Centrifuge/Product code: JQC)". This indicates the device includes physical components and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for processing adipose tissue for surgical procedures (autologous fat transfer). It's about preparing tissue for re-implantation into the patient, not for diagnosing a condition or providing information about a patient's health status based on in vitro analysis of a specimen.
- Device Description: The description focuses on the mechanical processing of harvested fat tissue to remove impurities and create a homogenous product for surgical use. It's a tissue processing device, not a diagnostic test.
- Lack of Diagnostic Claims: There are no claims or indications that the device is used to detect, measure, or analyze substances in a specimen to provide diagnostic information.
- Performance Metrics: The performance metrics listed (Nucleated Cell Count, Viability, pH, etc.) are related to the quality and characteristics of the processed adipose tissue itself, not to diagnostic markers or indicators of disease.
IVD devices are typically used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device is used to prepare tissue for use within the body.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
MUU
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.
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
Not Found
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)
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. | Pass |
| Measurement | When measuring with Vernier calipers, according to the dimension of 'shape and structure' part, the stated should be within ±5 %. | Pass |
| Leakage | When tested according to the test method, there should be no leakage. | Pass |
| 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 | Pass |
| Nucleated Cell Count | Nucleated cells should have more than 3.86x105 per ml of adipose tissue | Pass |
| Nucleated Cell Viability | Viability of nucleated cells should be more than 71.4% | Pass |
| Extraction test | ||
| Appearance | When observe sample preparation extract with naked eyes, there should not be foreign material. | Pass |
| pH | Difference in pH S: 1.5 | Pass |
| KMn04 Reducing agents | Difference intitres S: 2.0 ml | Pass |
| Evaporating residue | Difference in extractables S 1.0 mg | Pass |
| Heavy metal (as Pb) | Not darker than standard solution. | Pass |
| UV-vis Spectrum | Difference inabsorbance (250nm-350nm) S:0.1 | Pass |
Biocompatibility tests:
| # | Testitem | Test method /Test criteria | Test result |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 Tests for in vitro cytotoxicity | Pass |
| 2 | Skin Sensitization Test | ISO 10993-10 irritation and skin sensitization | Pass |
| 3 | Intracutaneous Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization test for delayed hypersensitivity | Pass |
| 4 | Acute Systemic Toxicity Test | ISO 10993-11 Test for systemic toxicity -Acute Systemic Toxicity | Pass |
| 5 | Pyrogen Test | ISO 10993-11Tests for systemic toxicity, Annex(F) Information on material-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 in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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
2
Indications for Use
510(k) Number (if known) K172717
Device Name Automatic Tissue Processing Unit
Indications for Use (Describe)
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
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) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k)Summary [as required by 807.92(c)]
1Applicant
-
- Company: BSLCo.
- Address: 6-13, Chilsan-ro 237beon-gil,Gimhae-si,Gyungsangnam-do, South Korea য
- Tel:82-55-328-9235 3)
-
- Fax:82-55-328-9236
- Prepared date: July 4, 2017 5)
-
- Contact person: Peter Chung,412-512-8802
- Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA 7)
-
- Submission date: August 25, 2017
2. Device Information
-
- Trade name: Automatic Tissue Processing Unit
- 2 Common name: Fat Concentration System
- 3 Regulation name: Suction Lipoplasty System
- 4 Product code: MUU
-
- Regulation number: 878.5040
- റ്റം Class of device: Class II
-
- Panel: General and Plastic surgery
-
- The legally marketed device to which we are claiming equivalence K121005, AdiPrep™Adipose Transfer System
4. 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.
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
4
6. Performance data:
-
- 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 Sensitization | ||
| Test | ISO 10993-10 irritation and skin sensitization | Pass | |
| 3 | Intracutaneous | ||
| Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization test | ||
| for delayed hypersensitivity | Pass | ||
| 4 | Acute Systemic | ||
| Toxicity Test | ISO 10993-11 Test for systemic toxicity -Acute Systemic Toxicity | Pass | |
| 5 | Pyrogen Test | ISO 10993-11Tests for systemic toxicity, Annex(F) Information on | |
| material-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.
5
7.ComparisonTable of ACPU-100/AC PU-200
| Manufacturer | BSL Co. | AdiprepTM | Remark |
|---|---|---|---|
| SIO(K) No. | K121005 | N/A | |
| Indication for | |||
| use | 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
- aparoscopic Surgery
- Arthroscopic Surgery | The AdiPrep™ Adipose Transfer System isused
in medical procedures involving the harvesting
and transferring of autologous adipose tissue.
The Adiprep system is used for concentrating
adipose tissue harvested with a legally
marketed lipoplasty system. AdiPrepTM Adipose
Transfer system 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
- 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 |
| Processing
Pack:Materials | ACPU-100 kit / ACPU-200 kit | Components - Syringes with removable
plunger, centrifuge tubes with filter, aspiration
& fat injection cannula,fat injection syringes,
skin puncture needles, and oil extraction
syringe & needle. Cannula & syringes
composed of medicalgrade plastics. | Different |
| Fill volumes | 5 to 25ml | 5 to 25ml | same |
| Sterilization
Method | Ethylene-OxideGas(EtO) | Ethylene-Oxide Gas (EtO) | same |
| Autologous Adipose Product | | | |
| Nucleated cell
count (x105 ml
of product) | 3.86 over | Mean 1.848 | Similar |
| Nucleated cell
viability | 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 at
1250 g-force (ACPU-200 kit)
Centrifuge to spin for approximately 5 minutes at
375 g-force (ACPU-100 kit) | Centrifuge to spin for approximately 4 minutes
at 1250 g-force | Same
and
different |
| Laboratory
centrifuge | ACS Combo-A Centrifuge
CENTRIFUGES (MICRO, ULTRA, REFRIGERATED)
FOR CLINICAL USE or laboratory centrifuge for
clinical use | SmartPReP2 centrifuge isa general-purpose
laboratory centrifuge for clinical use | N/A |
6
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.