(50 days)
The Twister™ Superelastic Ligating Clip, Size M, and its applier is intended for the permanent occlusion or ligation of blood vessels and other tubular body structures, wherever a metal ligating clip is indicated, and within the size range of 2.0 to 3.5mm diameter.
The Twister" Superelastic Ligating Clip System comprises a dedicated applier containing a number of Twister™ Superelastic Ligating Clips held in-train in an unstretched state. The applier consists of a front nozzle, handle and main body with a trigger. The clips are applied by a two stage trigger activation process of the applier; in the first step the clip is advanced and stretched to an open position, and in the second step the clip is released into position on the vessel or structure to be ligated. Prior to activation, the applier nozzle design allows for assessment of the suitability of a particular clip size in relation to that of the blood vessel, or other body tubular structure. Surgeons should only apply an appropriately sized clip for the size of vessel or tissue structure to be ligated, such that the clip completely encompasses the vessel or tissue structure. The specific nozzle design is intended to assist the surgeon in optimal clip application, by virtue of its shape and external guide markings.
The Twister™ clip is manufactured from a Superelastic Nitinol alloy, which has a shape memory effect. During application of the Twister™ clip, the clip is opened for placing over the vessel or structure. On its release from the applier, the Twister™ clip resumes its original 'shape memory' closed position, and its arms encircle the vessel or structure - effectively ligating the vessel or structure by applying a pressure.
The Twister™ clip and its applier are single use medical devices and both the applier and any remaining unused clips should be discarded following the surgical procedure The Twister applier and clips are not intended for re-sterilization.
The provided text is a 510(k) summary for the Twister™ Superelastic Ligating Clip and Applier. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or performance metrics like sensitivity, specificity, accuracy, or any sample sizes used for testing.
This 510(k) submission primarily focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The clinical purpose of the device.
- Substantial Equivalence: Arguing that it is similar enough to previously approved devices that new clinical trials are not necessary. This is a common pathway for Class II devices.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., "device must achieve X% accuracy").
- Reported Device Performance: Not reported in terms of specific sensitivity, specificity, or accuracy. The document states: "Differences between the subject device and the predicate devices were the subject of laboratory and animal studies to establish safety and effectiveness. The biocompatibility of the materials used in the subject device has also been established." However, no results or performance thresholds from these studies are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance: The document refers to "laboratory and animal studies," which suggests non-human data. The submitter is from the United Kingdom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC or human-in-the-loop study is mentioned. The focus appears to be on the device's physical properties and performance in non-human studies.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- This device is a physical medical instrument (ligating clip and applier), not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- Based on the mention of "laboratory and animal studies to establish safety and effectiveness," the ground truth would likely be established through direct observation of the device's mechanical performance (e.g., successful ligation, force required for closure, long-term stability in vitro or in animal tissue), and biological compatibility (e.g., lack of adverse tissue reaction). Pathology and outcomes data might have been gathered as part of these animal studies, but are not detailed.
8. The Sample Size for the Training Set
- Not applicable as this is not an AI/ML device. For physical device testing, "training set" is not a standard term. If "training" refers to initial developmental testing, those sample sizes are not provided.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for a physical device.
Summary of Missing Information:
This 510(k) summary is a high-level overview. Detailed study results, acceptance criteria, and methodology for evaluating performance (which would typically include expert involvement, ground truth establishment, and specific sample sizes) are not included in this public summary document. Such information would usually be found in the full 510(k) submission, which is not publicly available in this format, or in more detailed regulatory reports.
The FDA's statement ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") indicates that the FDA did review evidence (presumably including the detailed studies mentioned) and found it sufficient for clearance under the substantial equivalence pathway, rather than requiring a Pre-Market Approval (PMA) which would necessitate extensive clinical trials to prove safety and effectiveness.
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K032238 P1/2
Premarket Notification 510(k) Submission Neurosel (Medical) Ltd. TwisterTM
510(k) Summary
July 11th 2003
1 Submitter
Neurosel (Medical) Limited Greenways Abbotts Ann Andover Hampshire SP11 7BH United Kingdom
Contact: Prof. Peter Gibson +44 1264 711080 Tel: +44 1264 711083 Fax: E-mail: petergibson(@neurosel.co.uk
2 Name of Device
| Proprietary Name: | Twister™ Superelastic Ligating Clip and Applier, Size M |
|---|---|
| Common Name: | Clip, Implantable |
| Device Classification: | Implantable Clips have been placed in Class II as per 21 CFR Regulation Number 878.4300 and assigned the Product Code FZP |
3 Predicate Devices
The Twister™ Superelastic Ligating Clip and Applier is substantially equivalent to the following legally marketed devices:
| K830503 | Ethicon Ligaclip® Titanium Ligating Clip |
|---|---|
| K864102 | Ethicon Ligaclip® 20/20 Multiple Clip Applier |
4 Device Description
The Twister" Superelastic Ligating Clip System comprises a dedicated applier containing a number of Twister™ Superelastic Ligating Clips held in-train in an unstretched state. The applier consists of a front nozzle, handle and main body with a trigger. The clips are applied by a two stage trigger activation process of the applier; in the first step the clip is advanced and stretched to an open position, and in the
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K032238
$\rho_{2/2}$
second step the clip is released into position on the vessel or structure to be ligated. Prior to activation, the applier nozzle design allows for assessment of the suitability of a particular clip size in relation to that of the blood vessel, or other body tubular structure. Surgeons should only apply an appropriately sized clip for the size of vessel or tissue structure to be ligated, such that the clip completely encompasses the vessel or tissue structure. The specific nozzle design is intended to assist the surgeon in optimal clip application, by virtue of its shape and external guide markings.
The Twister™ clip is manufactured from a Superelastic Nitinol alloy, which has a shape memory effect. During application of the Twister™ clip, the clip is opened for placing over the vessel or structure. On its release from the applier, the Twister™ clip resumes its original 'shape memory' closed position, and its arms encircle the vessel or structure - effectively ligating the vessel or structure by applying a pressure.
The Twister™ clip and its applier are single use medical devices and both the applier and any remaining unused clips should be discarded following the surgical procedure The Twister applier and clips are not intended for re-sterilization.
5 Intended Use
The Twister™ Superelastic Ligating Clip, Size M, and its applier is intended for the permanent occlusion or ligation of blood vessels and other tubular body structures, wherever a metal ligating clip is indicated, and within the size range of 2.0 to 3.5mm diameter.
6 Summary of Substantial Equivalence
The Twister™ Superelastic Ligating clip and applier is similar in design, intended use and performance characteristics to the predicate devices. There are no new issues of safety of effectiveness raised by the subject device. Differences between the subject device and the predicate devices were the subject of laboratory and animal studies to establish safety and effectiveness. The biocompatibility of the materials used in the subject device has also been established.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
Professor Peter Gibson Neurosel (Medical) Limited Greenways Abbotts Ann Andover, Hampshire United Kingdom SP11 7BH
Re: K032238
Trade/Device Name: Twister™ Superelastic Ligating Clip and Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: July 17, 2003 Received: July 21, 2003
Dear Professor Gibson:
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 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 - Professor Peter Gibson
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 (301) 594-4659. 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,
Muriam C. Provost
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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Indications for Use Statement
Ует/3-4/24/96
Applicant: k
Neurosel (Medical) Ltd
510(k) Number (if known):
Device Name:
Twister™ Superelastic Ligating Clip and Applier
Indications For Use:
The Twister™ Superelastic Ligating Clip, Size M, and its applier is intended for the
permanent occlusion or ligation of blood vessels and other tubular body structures,
wherever a metal ligating clip is indicated, and within the size range of 2.0 to 3.5mm
diameter.
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K032238
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
8
K 032238
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.