(105 days)
The Tulip Disposable Cannula is intended for use in aesthetic body contouring.
The Tulip Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock® tip type or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites prelipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations. The Tulip Disposable Cannulas are single-use disposables, supplied sterile (e beam).
This document is a 510(k) summary for the "Tulip Disposable Cannulas" by Cell Bio-Systems, Inc. It details the device's substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria for a new technology or algorithm. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable.
However, I can extract the relevant information concerning the device's description and the rationale for its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence determination for a medical device (cannulas) and not an AI/algorithm-based device, there are no specific performance metrics like sensitivity, specificity, or F1 score with numerical acceptance criteria and reported performance in the context of an AI study. The "performance" is implicitly tied to safety and effectiveness, which are deemed substantially equivalent to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Rationale for SE) |
|---|---|
| Similar Design and Materials | The Tulip Disposable Cannulas are coated stainless steel cannulas. Predicate devices (Byron Medical, Richter LTDA) also consist of cannulas fabricated out of stainless steel. |
| Similar Intended Use | The Tulip Disposable Cannula is intended for use in aesthetic body contouring. Predicate devices are also designed for lipoplasty/liposuction and aspiration/infiltration for aesthetic body contouring. |
| No New Technology or Change in Indications for Use | Cell Bio-Systems states that "No new technology or change in indications for use have been introduced by Cell Bio-Systems in the manufacture of the Disposable Cannulas." |
| Sterility | The Tulip Disposable Cannulas are supplied sterile (e-beam). |
| Coating (addressed for equivalence) | Tulip Cannulas are provided with a hydrophilic coating. Predicate devices offer similar coatings (e.g., Byron cannulas offer PTFE or hydrophilic Slik-Tip coating; Richter cannulas offer PTFE coating). This difference is presented as not impacting substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is not a study testing an algorithm's performance on a dataset. It's a regulatory submission for substantial equivalence of a physical medical device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of an algorithm's performance, is not relevant to this type of device submission.
4. Adjudication method for the test set:
- Not applicable.
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:
- Not applicable. MRMC studies are used for evaluating diagnostic systems with human interpretation, typically AI models. This is a physical surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- Not applicable.
8. The sample size for the training set:
- Not applicable. This device did not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the document's relevance to the prompt:
This document is a 510(k) Premarket Notification for a medical device (Tulip Disposable Cannulas). The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This means that the new device has the same intended use as a predicate device, and the same technological characteristics as the predicate device; or has different technological characteristics from a predicate device but information is submitted that demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
The document does not describe a study involving acceptance criteria for an AI or algorithmic device, nor does it provide performance metrics from such a study. Instead, it establishes "substantial equivalence" based on:
- Identical intended use (aesthetic body contouring).
- Similar technological characteristics (stainless steel cannulas, various diameters, lengths, and tip configurations).
- Similar materials (stainless steel, with a note on coatings being comparable if not identical).
- No new technology or changes in indications for use.
The "study" here is essentially the comparison and justification provided in the 510(k) summary, arguing that the Tulip Disposable Cannulas meet the requirements for safety and effectiveness because they are fundamentally similar to approved predicate devices.
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Cell Bio-Systems, Inc. Christine Emanuel President 1205 De La Vina Street Santa Barbara, California 93101
June 8, 2021
Re: K060089
Trade/Device Name: Tulip Disposable Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Christine Emanuel:
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 April 27, 2006. 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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars extending from its head, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2006
Cell Bio-Systems, Inc. c/o Tecsa Technical Services Ms. Christine Emanuel Regulatory Consultant 1205 De La Vina Street Santa Barbara, California 93101
Re: K060089
Trade/Device Name: Tulip Disposable Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: March 22, 2006 Received: March 23, 2006
Dear Ms. Emmanuel:
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.
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
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Page 2 - Ms. Christine Emanuel
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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
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
510(k) Number (if known): K060089
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Tulip Disposable Cannula is intended for use in aesthetic body contouring.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
D/OR
Over-The
(21 CFR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milliman
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KO60089
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510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Cell Bio-Systems, Inc.438 Camino del Rio. So., Suite 219San Diego, CA 92108Phone: 858-244-4800Ed Semanik, Productionemail: ed@teamcbsi.comFax: 858-630-2941Contact Person for premarket notification:Christine Emanuel, Regulatory Consultant1205 De La Vina StreetSanta Barbara, CA 93101Phone: 805.963.4312Fax: 805.564.8642Email: cemanuel@west.net | APR 27 2006 |
|---|---|---|
| Date Prepared: | April 21, 2006 | |
| Device Name: | ||
| Proprietary Name: | Tulip Disposable Cannulas | |
| Common Name: | Liposuction Cannulas | |
| Classification: | Class II, MUU, 21 CFR 878.5040 |
Identification of Predicate Devices
- Byron Medical, Inc. Lipoplasty/Liposuction Aspiration and Tumescent Infiltration . Cannulae/Needles, 510(k) number K981172,
- Richter LTDA. Richter Lipoplasty Cannulas and Accessories, Richter LTDA, Sao . Pualo, SP-Brazil, CEP 05047-001; 510(k) number K990602
Device Description:
The Tulip Disposable Cannulas are coated stainless steel cannulas designed for connection to syringes (Luer Lock® tip type or hub adaptor). The cannulas are designed to be used with a syringe aspirator or syringe re-injector. There is also an infiltrator configuration available, to administer a solution to surgery sites prelipoplasty. The cannulas are made of hydrophilic coated stainless steel, and are available in various diameters, lengths and tip configurations.
The Tulip Disposable Cannulas are single-use disposables, supplied sterile (e beam),
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The Tulip Disposable Cannula is intended for use in aesthetic body Indication for Use: contouring.
Technological Characteristics
The design, use, and materials of the Tulip Disposable Cannulas and their predicate devices are equivalent, in that all these cannulas are designed to be used for aesthetic body contouring and are fabricated out of stainless steel. Tulip Cannulas are all provided with a hydrophilic coating. The Byron cannulas provide the option of a PTFE or hydrophilic Slik-Tip coating to their users and the Richter cannulas provide the option of PTFE coating to their users. No new technology or change in indications for use have been introduced by Cell Bio-Systems in the manufacture of the Disposable Cannulas. For these reasons, Cell Bio-Systems considers the use of the Tulip Disposable Cannulas to be substantially equivalent to their predicate devices
§ 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.