(47 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of ligating clips and their accessories, with no mention of AI or ML.
No
The device is described as single-use, non-active implantable clips used for ligating vessels or tissue structures in surgical procedures, which does not align with the definition of a therapeutic device that actively treats a disease or condition.
No
Explanation: The device is a ligating clip used to ligate vessels or tissue structures during surgical procedures. It is a surgical tool, not a device that diagnoses conditions.
No
The device description explicitly states that the device is a "single-use, non-active implantable device" manufactured from a "non-absorbable acetyl polymer," clearly indicating a physical hardware component.
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 designed for use in general surgical procedures that require vessel or tissue ligation." This further reinforces its use within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The Hem-o-lok® Ligating Clips do not perform any such function. They are a surgical tool used on the patient.
Therefore, the Hem-o-lok® Ligating Clips are a surgical device, not an IVD.
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, 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
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)
Non-clinical performance testing has been conducted in accordance with ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems in order to support changes to the materials used to package the Hem-o-lok® Ligating Clips. In addition, cleaning and sterilization validations were performed to assess manual and automated cleaning processes as well as pre-vacuum and gravity steam sterilization processes for Hem-o-lok® manual, reusable clip appliers and removers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K133202 Page 1/3
510(k) SUMMARY
Hem-o-lok® Ligating Clips
DEC 3 0 2013
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8065 919-433-4996 Fax:
B. Contact Person
Ashlea Ricci, RAC Senior Regulatory Affairs Specialist
Lorraine DeLong Manager RA/QE Surgical
C. Date Prepared
November 8, 2013
D. Device Name
| Trade Name: | Hem-o-lok® Ligating Clips |
|---|---|
| Common Name: | Implantable Clips |
| Classification Name: | Clips, Implantable |
| Product Code: | FZP |
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, 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.
Teleflex Medical, Inc.
CONFIDENTIAL
1
F. Indications for Use
Page 2/3 K133202
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.
G. Contraindications
Hem-o-lok® Ligating Clips are not intended for use as a 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.
I. Substantial Equivalence
The proposed Hem-o-lok® Ligating Clips are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Hem-o-lok® Ligating Clips | Teleflex Medical | ||
| (Weck) | K062914 | 11/2/2006 | |
| Hem-o-lok® Ligating Clips | Teleflex Medical | ||
| (Weck) | K030311 | 2/6/2003 |
J. Comparison To Predicate Devices
The proposed Hem-o-lok® Ligating Clips have the same technology and functional characteristics as the predicate systems. The proposed modifications include the addition of magnetic resonance (MR Safe) claims, addition of cleaning and sterilization instructions for reusable instrumentation, the addition of a three-clip configuration, and a change in packaging materials.
K. Materials
All patient contacting materials are in compliance with ISO10993-1.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Hem-o-lok® Ligating Clips and the predicates has been performed. The results of this comparison demonstrate that the Hem-o-lok® Ligating Clips are equivalent to the marketed predicate devices.
CONFIDENTIAL
2
M. Performance Data
Non-clinical performance testing has been conducted in accordance with ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems in order to support changes to the materials used to package the Hem-o-lok® Ligating Clips. In addition, cleaning and sterilization validations were performed to assess manual and automated cleaning processes as well as pre-vacuum and gravity steam sterilization processes for Hem-o-lok® manual, reusable clip appliers and removers.
N. Conclusion
Based upon the comparative test results, the proposed Hem-o-lok® Ligating Clips are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K062914 and K030311. The modifications made to the proposed Hem-o-lok® Ligating Clips do not introduce any new issues of safety and effectiveness.
3
Image /page/3/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 30, 2013
Teleflex Medical Incorporated Ashlea Ricci, RAC 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K133202
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: October 11, 2013 Received: November 04, 2013
Dear Ms. Ricci:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 -- Ashlea Ricci, RAC
۰۰:۰۰:۰۰:۰۰: 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Binita S. Ashar - S 2013.12.30 15:34:33 -05'00'
Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Hem-o-lok Ligating Clips Traditional 510(k) - Page 46 of 578
Indications for Use
Page 1 of 1
510(k) Number:
K 133202
Device Name:
Hem-o-lok® Ligating Clips
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K133202