(125 days)
The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Stars2000 Power Cannula," a suction lipoplasty system. It does not contain information about acceptance criteria, study details, or device performance metrics.
The letter primarily focuses on:
- Notifying the applicant of an administrative change (new product code).
- Confirming the substantial equivalence determination made in 2001.
- Outlining the regulatory requirements for marketing the device.
- Stating the intended use of the device.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, or standalone performance) from the provided text. This type of information would typically be found in the 510(k) submission itself, not in the clearance letter.
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Kmi Kolster Methods, Inc. Alwin Kolster CEO 1170 N. Gilbert St. Anaheim, California 92801
June 8, 2021
Re: K012236
Trade/Device Name: Stars2000 Power Cannula Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Alwin Kolster:
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 November 19, 2001. 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 Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by a serpent and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2001
Mr. Alwin H. Kolster Kolster Methods, Inc. 1170 North Gilbert Street Anaheim, California 92801
Re: K012236
Trade Name: Stars 2000 Power Cannula Regulation Number: 878.5040 Regulation Name: Suction Lipoplasty Regulatory Class: II Product Code: MUU Dated: October 23, 2001 Received: October 24, 2001
Dear Mr. Kolster:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Mr. Alwin Kolster
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, ms
Image /page/2/Picture/5 description: The image shows a signature or stylized symbol. It consists of a curved line that forms a loop at the top, resembling a cursive letter. The line then extends downwards and to the right, ending in a small, sharp curve. The overall impression is that of a quick, fluid stroke, possibly representing initials or a unique mark.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K012236-A1
NOV 1 9 2001
| Page | of |
|---|---|
| 510(k) Number (if known): | K012236 |
| Device Name: | Stars 2000 |
| Indications For Use: |
Indication for use statement
The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
A lwin H. Kolster
Kolesky
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walker
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Ko12236 510(k) Number Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ ાર
Prescription Use_ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
-1/21
§ 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.