(101 days)
The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.
The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.
The provided document, a 510(k) Pre-Market Notification for the Miltex Ligating Clip, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving those criteria are met. Therefore, much of the requested information cannot be found in the provided text.
Here is what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document states that the Miltex Ligating Clip functions "in the same manner as the predicate device" and is "as safe, as effective, and performs as well as the Horizon Ligation System (K982313)."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Is biocompatible |
| Non-endotoxic | Is not endo-toxic |
| Supplied sterile | Is supplied sterile |
| Occludes blood flow within small, non-intracranial vessels | Functions to occlude blood vessels (same as predicate device) |
| Same material as predicate device | Composed of the same CP Grade 1 titanium wire |
| Same design/shape as predicate device | Is the same chevron-shape as the predicate device |
| Virtually identical size to predicate device when closed | Virtually identical in size to predicate device when closed |
| Disposable holder plastic equivalent to predicate device's | Disposable holder is a plastic equivalent to predicate device's |
| Secure retention on the vessel (due to grooves) | Tissue will fill in grooves, providing secure retention |
| Improved occluding functions (due to grooves) | Improves the occluding functions |
| Minimizing possibility of scissoring (due to distal flat ends) | Minimizing the possibility of scissoring |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The submission relies on a comparison to a predicate device rather than a new clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as there's no mention of a test set or ground truth established by experts in this context. The claim is based on substantial equivalence to the predicate device.
4. Adjudication method for the test set:
This information is not provided as there's no mention of a test set.
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:
This is not applicable. The device is a physical ligating clip, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical ligating clip, not an algorithm.
7. The type of ground truth used:
This information is not explicitly stated in the context of a "ground truth" for a study. The "truth" in this submission relies on demonstrating the physical and functional similarity to a legally marketed predicate device. This is a regulatory pathway of "substantial equivalence" rather than proving new efficacy from scratch.
8. The sample size for the training set:
This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.
9. How the ground truth for the training set was established:
This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.
In summary, the Miltex Ligating Clip's acceptance relies not on a clinical trial with specific performance criteria and ground truth, but on demonstrating "substantial equivalence" to a legally marketed predicate device (Horizon™ Ligation System by Weck Closure Systems, K982313) based on material, design, dimensions, and intended use. The document asserts that due to these similarities, the Miltex Ligating Clip is "as safe, as effective, and performs as well" as the predicate.
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page 1 of 2
FDA 510(k) Pre-Market Notification Miltex Ligating Clip
<052018
589
589 Davies Drive
phone 717 840-9335
toll-free 800 221-1344
fax 717 840-9347
Miltex.
Redefining Excellence
NGV - 4 2005
510(k) Summary [as required by 21 CFR 8807,92(c)]
510(k) Owner's Name and Address: Miltex, Inc. 589 Davies Drive York, PA 17402
Contact Information: Telephone 717-840-9335, Fax 717-840-9347 Contact Person: Lee Zagar, Vice President Quality Assurance and Regulatory Affairs Date Summary Prepared: September 12, 2005
Device Trade Name: Miltex Ligating Clip. Device Common Name: Ligating Clip. Classification Name: Clip, Vascular (21 CFR 870.3250, Product Code DSS)
Predicate Device: Horizon™ Ligation System by Weck Closure Systems- K982313
Device Description: The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.
Intended Use: The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.
Technological Characteristics: The Miltex Ligating Clip has the same technological characteristics as the predicate device. The clip is composed of the same titanium material as the predicate device. In shape, the Clip is the same as the predicate device. When closed, the Clip is virtually identical in size to the predicate device. The disposable holder is a plastic equivalent to the predicate device's.
Page 8-1. rev 1
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jan 27
FDA 510(k) Pre-Market Notification Miltex Ligating Clip
Performance Data: When used with the appropriate clip applier, the Miltex Ligating Clip functions in the same manner as the predicate device to occlude blood vessels. The clip is biocompatible, is not endo-toxic, and is supplied sterile.
Conclusion:
Because the Miltex Ligating Clip is composed of the same material, has the same design and dimensions, and is supplied sterile, it is as safe, as effective, and performs as well as the Horizon Ligation System (K982313).
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Image /page/2/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 lines representing its wings and head. 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
NOV - 4 2005
Charles Weaver Regulatory Affairs Coordinator Miltex, Inc. 589 Davies Drive York, Pennsylvania 17402
Re: K052018
Trade/Device Name: Miltex Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: October 12, 2005 Received: October 13, 2005
Dear Mr. Weaver:
We have reviewed your Scction 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 10 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 gencral 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 fisting (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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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) 276-0120. 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/industry/support/indcx.html.
Sincercly yours,
barbare Buchner
for
Mark N. Melkerson Acting 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): K052018
Device Name: Miltex Ligating Clip
Indications for Usc:
The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Darban Bonerlubert Cloud D.R.f. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative, Page 1 of 1
and Neurological Devices
| 510(k) Number | R05 2018 |
|---|---|
| --------------- | ---------- |
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§ 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.