(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a non-active implantable device, with no mention of AI or ML.
No.
The device is a ligating clip used to close vessels or tissue structures during surgery. While it aids in a surgical procedure, its primary function is mechanical closure, not the treatment or cure of a disease or condition in a therapeutic sense.
No
The device is described as a liganing clip used in surgical procedures to ligate vessels or tissue structures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device is a "single-use, non-active implantable device" made from an "acetyl polymer," which are physical materials, not software. The performance studies also focus on benchtop testing of physical properties and biocompatibility, further indicating a hardware device.
Based on the provided information, the Hem-o-lok® Ligating Clips are not an In Vitro Diagnostic (IVD) device.
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 described as a "single-use, non-active implantable device" used in "general surgical procedures." This further reinforces its use within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Hem-o-lok® Ligating Clips do not perform this function.
The device is a surgical tool used on the patient, not a device used to test samples from the patient.
N/A
Intended Use / Indications for Use
Hem-o-lok® 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 the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Product codes
FZP
Device Description
Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons; general surgical procedures
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
Non-clinical performance testing, consisting of benchtop verification testing for clip latching, resistance to leakage, and clip removal, has been conducted following product sterilization, environmental conditioning, simulated distribution, and accelerated aging in order to ensure the device performed equivalently to the predicate.
The following biocompatibility endpoints were assessed per ISO 10993-1:
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Intracutaneous Reactivity per ISO 10993-10
- Systemic toxicity (acute) per ISO 10993-11
- Subchronic toxicity (subacute) per ISO 10993-11
- Implantation per ISO 10993-6
- Material Mediated Pyrogenicity per ISO 10993-11
- Chronic Toxicity per ISO 10993-11
- Genotoxicity per ISO 10993-3
- Carcinogenicity per ISO 10993-3
- Chemical Characterization per ISO 10993-18
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 12, 2024
Teleflex Medical Hope West Principal Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K232970
Trade/Device Name: Hem-o-lok® Ligating Clips Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: September 20, 2023 Received: September 21, 2023
Dear Hope West:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232970
Device Name Hem-o-lok® Ligating Clips
Indications for Use (Describe)
Hem-o-lok® 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 the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
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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C)
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K232970 510(k) SUMMARY
Hem-o-lok® Ligating Clips
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-544-8000 919-433-4996 Fax:
B. Contact Person
Hope West. RAC-Devices. Pr. Regulatory Affairs Specialist
C. Date Prepared
10 January 2024
D. Device Name
| Trade Name: | Hem-o-lok® Ligating Clips |
|---|---|
| Common Name: | Implantable Clip |
| Classification Name: | Clip, Implantable |
| Product Code: | FZP, 21 CFR 878.4300 |
E. Device Description
Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
F. Indications for Use
Hem-o-lok® 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 the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
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G. Contraindications
Hem-o-lok® Ligating Clips are not intended for use as a fallopian contraceptive tubal occlusion device.
Hem-o-lok® Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.
H. Environmental Conditions
Hem-o-lok® Ligating Clips are "MR Safe" and pose no known hazards in MR environments.
l. Substantial Equivalence
The proposed Hem-o-lok® Ligating Clips are substantially equivalent to the predicate device with respect to technology, intended use, indications and technological characteristics:
| New Submission | Predicate | Equivalence | |
|---|---|---|---|
| 510(k) Number | K232970 | K133202 | N/A |
| Device Name | Hem-o-lok® Ligating Clips | Hem-o-lok® Ligating Clips | Identical |
| Product Code | FZP | FZP | Identical |
| Regulation | 878.4300 | 878.4300 | Identical |
| Intended Use | Ligation of vessels and tissue structures | Identical | |
| Indications for | |||
| Use | Hem-o-lok® 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 the vessel or tissue structures to be | |||
| ligated such that the clip completely encompasses the vessel or tissue | |||
| structure. | Identical | ||
| Contraindications | Hem-o-lok® Ligating Clips are not intended for use as a fallopian | ||
| contraceptive tubal occlusion device. | |||
| Hem-o-lok® Ligating Clips are contraindicated for use in ligating the renal | |||
| artery during laparoscopic donor nephrectomies. | Identical | ||
| Clip Size Offering | Medium, Medium-Large, Large, | ||
| Extra-Large | Medium, Medium-Large, Large, | ||
| Extra-Large | Identical | ||
| Clip Material | Acetyl Polymer | Acetyl Polymer | Equivalent |
| Clip Design | Hinged, bow-shape clip with bosses | ||
| for clip retention within the appliers, | |||
| and a locking mechanism | Hinged, bow-shape clip with bosses | ||
| for clip retention within the appliers, | |||
| and a locking mechanism | Identical | ||
| Cartridge Design | Easy Load with lateral springs | Easy Load with lateral springs | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Equivalent |
| Sterilization | Ethylene Oxide (EO); SAL 10-6 | Ethylene Oxide (EO); SAL 10-6 | Equivalent |
6
J. Performance Data
Non-clinical performance testing, consisting of benchtop verification testing for clip latching, resistance to leakage, and clip removal, has been conducted following product sterilization. environmental conditioning, simulated distribution, and accelerated aging in order to ensure the device performed equivalently to the predicate.
The following biocompatibility endpoints were assessed per ISO 10993-1:
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Intracutaneous Reactivity per ISO 10993-10
- Systemic toxicity (acute) per ISO 10993-11
- Subchronic toxicity (subacute) per ISO 10993-11
- Implantation per ISO 10993-6
- Material Mediated Pyrogenicity per ISO 10993-11
- Chronic Toxicity per ISO 10993-11
- Genotoxicity per ISO 10993-3
- Carcinogenicity per ISO 10993-3
- Chemical Characterization per ISO 10993-18
K. Conclusion
Based upon the performance and comparative test results, the proposed Hem-o-lok® Ligating Clip (K232970) is substantially equivalent in performance to the predicate device cleared to market via 510(k) K133202. The proposed device does not introduce any new issues of safety and effectiveness.