(167 days)
Not Found
No
The summary describes a mechanical surgical clip and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for ligation of vessels or tissue structures, which is a supportive surgical function, not a direct therapeutic intervention for disease treatment, diagnosis, or prevention.
No
Explanation: The device is a ligating clip intended for surgical procedures, specifically for ligating vessels or tissue structures. Its description and intended use focus on mechanical ligation, not on diagnosing medical conditions.
No
The device description explicitly states that the device is a permanent implant, non-absorbable, sterile, surgical clip made from Titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ligation of vessels or tissue structures" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a "permanent implant, non-absorbable, sterile, surgical clip." This describes a surgical tool and implant, not a device used to examine specimens from the body.
- Mechanism of Action: The mechanism involves physically closing a clip on a vessel or tissue. This is a mechanical action within the body, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
Product codes (comma separated list FDA assigned to the subject device)
FZP, DSS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial Equivalence analyses preformed:
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.
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.
Quantitative - angiOCCLUDE clip closure testing proved that the clips are secure in the applier, and release from applier's jaws equivalent to Horizon.
Qualitative - dimensional/geometry comparisons using precise overlays prove that angiOCCLUDE and Teleflex Horizon clips are the same size.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 878.4300 |
| DSS 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.
4
- 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.