(158 days)
The VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for the intended use of figure occlusion of vessels and prevent any slippage once applica. The clip masters is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The clip can be left in vivo without sequela as it is biologically inert.
The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
Acceptance Criteria and Device Performance Study for Titanium Hemostatic Clip
This document describes the acceptance criteria for the Vitalitec International, Inc. Titanium Hemostatic Clip and the supporting data demonstrating its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Reference |
|---|---|---|
| Material Composition | ||
| Meet ASTM F-67 95, Grade I Titanium standards | Device composed of ASTM F-67 95, Grade I Titanium | Data Summary (Page 1) |
| Meet ISO 5832-2-93, Grade I Titanium standards | Device composed of ISO 5832-2-93, Grade I Titanium | Data Summary (Page 1) |
| Biologically Inert | Device clips are biologically inert; can be left in vivo without sequela | Indications For Use (Page 3) |
| Intended Use & Functionality | ||
| Effective for ligation of blood vessels | Hemostatic clip effectively ligates blood vessels | Data Summary (Page 1) |
| Ensures complete occlusion of vessels | Clip designed to ensure complete occlusion of vessels | Indications For Use (Page 3) |
| Prevents slippage once applied | Clip designed to prevent slippage once applied | Indications For Use (Page 3) |
| Wide acceptance of method for hemostatic control | Millions of clips applied yearly since 1963, attesting to wide acceptance | Safety and Efficacy Information (Page 1) |
| Manufacturing Standards | ||
| Manufactured according to cGMP's | Device manufactured according to cGMP's | Data Summary (Page 1) |
| Manufactured according to AAMI and ASTM requirements | Device manufactured according to AAMI and ASTM requirements | Data Summary (Page 1) |
| Manufactured according to applicable Harmonized Standards ISO 9002/EN 46002 | Device manufactured according to applicable Harmonized Standards ISO 9002/EN 46002 | Data Summary (Page 1) |
| Sterility | Supplied sterile | Clips are supplied sterile |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe specific device performance testing with a "test set" in the traditional sense of a clinical trial or algorithm validation. Instead, the safety and efficacy information relies on:
- Data Provenance: The primary basis for safety and efficacy is stated as "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." This suggests a reliance on a retrospective analysis of widespread clinical use and long-term historical data for titanium hemostatic clips in general, rather than a prospective study on the specific Vitalitec device.
- Sample Size: No specific sample size or cohort is mentioned for a dedicated "test set" for this particular device. The "millions of clips" reference implies a very large, real-world population of patients who have received titanium hemostatic clips, though this is not a controlled sample.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since evidence is based on widespread historical use rather than a specific test set requiring ground truth establishment by experts, this information is not applicable in the context of the provided document. The "ground truth" seems to be established through the long-standing clinical acceptance and observation of outcomes over decades of use by numerous medical professionals.
4. Adjudication Method for the Test Set
As there is no described test set requiring expert adjudication for specific cases, this information is not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a physical medical device (titanium hemostatic clip), not an AI algorithm or imaging device that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the safety and efficacy of the Titanium Hemostatic Clip is based on:
- Long-term Clinical Outcomes Data: The statement "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control" indicates reliance on decades of real-world clinical experience and observed patient outcomes for titanium hemostatic clips.
- Expert Consensus/Clinical Acceptance: The "wide acceptance" by the medical community of this method of hemostasis serves as a form of ground truth based on collective expert experience and consensus.
- Material Standards Compliance: Ground truth for material composition is established by compliance with recognized international standards (ASTM F-67 95, ISO 5832-2-93).
- Predicate Device Equivalence: The safety and efficacy are also heavily supported by the "substantial equivalence" claim to predicate devices, which implies that the safety and performance characteristics are well-established for similar products already on the market.
8. The Sample Size for the Training Set
This product is a physical medical device. There is no concept of a "training set" as would be used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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OCT 1 3 1998
510(k) Summarv / Statement VITALITEC INTERNATIONAL, Inc. Submitters Name: 15 Caswell Lane, 3rd. Fl. Plymouth, MA 02360 Fax: 508-747-5118 Ph: 508-747-6033 Ellen Henke-Knupp, Regulatory Director Contact Name:
Titanium Hemostatic Clip Name of Device:
SAFETY & EFFECTIVENESS DATA SUMMARY
Classification Name: Clip, Implantable Common/Usual Name: Titanium Hemostatic Clip Proprietary Name: N/A at this time
| Classification: Class II | |
|---|---|
| Implantable Clip | #79 FZP Reg. # 878.4300 |
| Hemostatic Clip | #79 MCH Reg.# 878.4300 |
Performance Standards: Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002.
ASTM F-67 95, Grade I Titanium. Material Composition: ISO 5832 - 2- 93, Grade I Titanium Intended Use: An implantable Hemostatic clip intended for the ligation of blood vessels.
Device Description: The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".
Predicate Devices: EISNER USA Titanium Hemoclip K972745, Baxter Healthcare Vitaclip @ K953258; Edward Weck & Company, Pre-Amendment Hemoclip ® Surgical Occluding System and Hemoclip® Surgical Occluding Clip-Stainless Steel K800079; United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021.
Comparison of Technological Characteristics: The titanium clip material is identical to the predicate devices. In function, the clips are the same as the predicate devices. The disposable holder is a polycarbonate plastic equivalent to the predicate devices.
Safety and Efficacy Information: The titanium itself is well recognized as being safe and effective for long term implant. The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control.
PAGE 5
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. In the center of the seal is an abstract image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Ms. Ellen Henke-Knupp Requlatory Director Vitalitec International, Inc. 15 Caswell Lane 3rd Floor Plymouth, Massachusetts 02360
Re: K981645 Trade Name: Implantable Titanium Hemostatic Clip Requlatory Class: II Product Code: FZP Dated: August 14, 1998 Received: August 17, 1998
Dear Ms. Henke-Knupp:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
(S. N. Mr. Whitney Blue Cross-Blue Shield
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a handwritten string of characters, "K981645". Below this string, the text "Page 1 of 1" is written, indicating that this is page 1 of 1. The handwriting is somewhat stylized, with thick strokes and distinct letterforms.
$10(k) Number (if known):
Implantable Titanium Hemostatic Clip Device Name:
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Indications For Use:
(P
VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for The The VITALITEC INTERNATIONAD, INC. INC. Insures of me clip has been the intended use of figure occlusion of vessels and prevent specially designed to insure books applications in many any sirppage once applica. The cap masters is required or radiographic marking is necessary.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K981645
510(k) Number
| Prescription Use | X |
|---|---|
| (P 1 CFR 801.109) |
OR
Over-The-Counter Use(Optional Format 1-2-96)
§ 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.