(167 days)
angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).
The provided text describes a 510(k) submission for the "angiOCCLUDE Ligating Clips" aiming for substantial equivalence to the Teleflex Medical Horizon Ligating Clips. This document primarily focuses on regulatory approval based on comparison to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical study would for an AI-powered diagnostic device.
However, I can extract the "performance data" that was summarized to show substantial equivalence, which can be thought of as criteria for demonstrating equivalence to the predicate device.
Here's the breakdown based on your request, with an important note that this is not a clinical study of device performance against specific clinical acceptance metrics, but rather a comparison study for substantial equivalence according to FDA 510(k) regulations:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device. In this instance, the criteria are based on direct comparison to the Teleflex Medical Horizon Ligating Clips.
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (angiOCCLUDE Ligating Clips) |
|---|---|
| Mechanical/Functional Equivalence: | |
| - Closure over vessels | Both will close over vessels. |
| - Clip closure testing (security in applier, release from applier's jaws) | Proven that the clips are secure in the applier and release from applier's jaws equivalent to Horizon. |
| - Mechanism of action (cartridge/clip design, symmetrical leg pivoting) | Same between angiOCCLUDE and Horizon; cartridge and clip design allows for an applier to easily load a clip, and clips are then removed for use. When the clip is closing, the symmetrical legs pivot in from a centered apex as clips are closed. |
| - Dimensional comparison (open and closed state within applier) | Resulted in having the same function as Horizon when clips are applied and closed. |
| - Dimensional/geometry comparisons (using precise overlays) for clip size | Proven that angiOCCLUDE and Teleflex Horizon clips are the same size across the five provided sizes (MC, SML, M, M/L, and LG). |
| Material Equivalence: | |
| - Clip material | Same clip material: implantable grade of titanium. |
| - Material comparisons (formed and sterilized material safety) | Proven that the formed and sterilized material used for the angiOCCLUDE clip is as safe and the same as the material used in Teleflex Horizon. |
| Clinical Application Equivalence: | |
| - Indications and Contraindications | Same clinical application for indications and contraindications. |
| Manufacturing/Convenience Equivalence: | |
| - Cartridge color coding | Cartridges are color coded to match applier ring colors. |
| - Sterilization processing | Uses traditional EO sterilization processing. |
| - Packaging | Uses peel open blister packs with either 6 or 24 clips each. |
| - Clip forming method | Uses 4-slides to form the clips. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or AI performance evaluation. Instead, the "study" is a comparison conducted by the manufacturer against the predicate device. The sample sizes for the quantitative and qualitative performance analyses are not explicitly stated (e.g., number of clips tested for closure, number of units measured for dimensions). The "data provenance" is internal testing and comparison performed by A2 Medical Systems, LLC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The study described is a technical and material comparison, not one requiring expert human interpretation or establishment of ground truth in a diagnostic sense.
4. Adjudication Method
Not applicable as there is no human interpretation or diagnostic ground truth to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a surgical clip, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This device is a physical surgical clip, not an algorithm. Therefore, a standalone performance study without human-in-the-loop performance, in the context of AI/algorithms, is not applicable. The performance studies conducted were mechanical and material comparisons, as outlined in the table above.
7. Type of Ground Truth Used
The "ground truth" here is the established design, material properties, and performance characteristics of the legally marketed predicate device (Teleflex Medical Horizon Ligating Clips), against which the new device is compared. This is based on demonstrable physical properties and existing regulatory acceptance of the predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device. The "ground truth" for the comparison was the predicate device's characteristics.
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September 19, 2023
A2 Medical Systems, LLC Robert Hall Chief Operating Officer 6387 Technology Ave. Kalamazoo, Michigan 49009
Re: K230966
Trade/Device Name: angiOCCLUDE Ligating Clips Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, DSS Dated: August 15, 2023 Received: August 16, 2023
Dear Robert Hall:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tek N.
Lamichhane -S
Digitally signed by
Tek N. Lamichhane -S
Date: 2023.09.19
11:09:21 -04'00'
Tek N. Lamichhane, Ph.D. 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
Enclosure
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Indications for Use
510(k) Number (if known) K230966
Device Name angiOCCLUDE Ligating Clip
Indications for Use (Describe)
angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
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510(k) Summary
510(k) Number: K230966
Name, Address, Phone and Fax Number of Applicant
Owner: Andy Ambro Phone #: 336-706-6027 Address: A2 Medical Systems, LLC
6387 Technology Ave. Suite F Kalamazoo, MI 49009
Contact Person
Robert Hall Chief Operating Officer Address: A2 Medical Systems, LLC 6387 Technology Ave. Suite F Kalamazoo, MI 49009
Date Prepared: September 18, 2023
A. Device Name
| Trade Name: | angiOCCLUDE Ligating Clip |
|---|---|
| Common Name: | Hemostatic Clip, Ligating Clip |
| Classification Name: | Clip, Implantable |
| B. Device Classification: | Class II |
|---|---|
| Classification Panel: | Cardiovascular & General Surgery |
| Product Codes: | FZP per 878.4300DSS per 870.3250 |
C. Predicate Devices
Teleflex Medical Horizon Ligating Clips (510ks; K901303, K982313), Product Codes: DSS (870.3250) and FZP (878.4300)
D. Clip Device Description
AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).
نن Clip Indications for Use
angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
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- F. Contraindications: angiOCCLUDE ligating clips are never intended for use as a contraceptive tubal occlusion device. This product is also contraindicated when ligating the renal artery during minimally invasive donor nephrectomies.
G. Characteristic Comparison to Predicate Device Equivalence
The A2 Medical Systems titanium ligating clips are substantially equivalent to the predicate device Horizon in design and use.
- a. Substantially Equivalent areas are:
- i. Both will close over vessels
- ii. Both have the same clip material; implantable grade of titanium
- iii. Both have the same clinical application for indications and contraindications
- iv. Both have the same mechanism of action – cartridge and clip design allows for an applier to easily load a clip and clips are then removed for use. When the clip is closing the symmetrical legs pivots in from a centered apex as clips are closed.
-
Of the five sizes provided MC, SML, M, M/L, and LG; they have the same geometry.
- vi. Both have cartridges that are color coded to match applier ring colors
- vii. Both use traditional EO sterilization processing
- viii. Both use peel open blister packs with either 6 or 24 clips each.
- ix. Both use 4-slides to form the clips
- b. Differences:
- i. A2 Medical Systems titanium clips are made in the USA and Horizon is made in Mexico.
H. Summary of Performance Data
AngiOCCLUDE ligating clips are made of an implantable grade of Titanium with similar dimensions and metallurgical characteristics as the Teleflex Medical Horizon ligating clips.
- a. Substantial Equivalence analyses preformed:
- i. A2 Medical Systems angiOCCLUDE clip to predicate clip dimensional comparison was completed at an open and closed state within an applier that resulted in having the same function as Horizon when clips are applied and closed.
- ii. Both material comparisons prove that the formed and sterilized material used for the angiOCCLUDE clip is as safe and the same as the material used in Teleflex Horizon.
- iii. Quantitative - angiOCCLUDE clip closure testing proved that the clips are secure in the applier, and release from applier's jaws equivalent to Horizon.
- iv. Qualitative - dimensional/geometry comparisons using precise overlays prove that angiOCCLUDE and Teleflex Horizon clips are the same size.
- v. Mechanism of action is the same between angiOCCLUDE and Horizon; cartridge and clip design allows for an applier to easily load a clip, and clips are then removed for use. When the clip is closing the symmetrical legs pivots in from a centered apex as clips are closed.
In summary, the A2 Medical Systems titanium Ligation clips are the same in design, material, and function to the predicate device.
l. Statement of Substantial Equivalence
The angiOCCLUDE® Ligating Clips are substantially equivalent to their predicate device; the Teleflex Medical Horizon® Ligating Clips (K901303, K982313), based upon similarities in intended use, design, principles of operation and performance specifications.
§ 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.