(65 days)
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No
The document describes a mechanical ligating clip applier and does not mention any AI or ML components or functionalities.
No.
The device is described as an applier for ligating clips, which are used to ligate vessels or tissue structures. It is not described as providing therapy directly but rather as a surgical tool for a specific procedure.
No
Explanation: The device is a surgical ligating clip applier used for procedures involving ligation of vessels or tissue structures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, sterile, disposable endoscopic applier with a trigger grip handle, shaft, and knob, indicating it is a hardware device. There is no mention of software as the primary or sole 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 the 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 surgical instrument (an applier for ligating clips) used within the body during a procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to diagnose, monitor, or screen for diseases or conditions. This device is clearly used in vivo (within the body) for a surgical purpose.
N/A
Intended Use / Indications for Use
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
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.
Product codes
FZP, GDO
Device Description
The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
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
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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
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Summary of Performance Studies
Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support device modifications and ensure the device performed equivalently to the predicate.
Usability and design validation of the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier in a simulated use environment was conducted to document that the user was able to operate the system as intended, and the product conformed to user needs.
Key Metrics
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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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2023
Teleflex Medical Hope West Senior Regulatory Affairs Specialist 3015 Carrington Mill Blyd Morrisville, North Carolina 27560
Re: K230480
Trade/Device Name: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, GDO Dated: February 21, 2023 Received: February 22, 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 (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,
Tajanay R. Ki -S
Digitally signed by Taianav R. Ki -S Date: 2023.04.28 17:06:11 -04'00'
for Deborah Fellhauer RN. BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230480
Device Name Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
Indications for Use (Describe)
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
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.
| 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 - K230480 - 28April2023
Weck® Auto Endo5® 5mm Automatic Endoscopic 35cm Applier
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, Sr. Regulatory Affairs Specialist
C. Date Prepared
February 21, 2023
D. Device Name
| Trade Name: | Weck Auto Endo5® 5mm Automatic Endoscopic 35cm Applier |
|---|---|
| Common Name: | Implantable Clip |
| Classification Name: | Applier, Surgical, Clip |
| Clip, Implantable | |
| Product Code: | GDO, |
| FZP |
E. Predicate Device
The proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Product Code | Date
Cleared |
|---------------------------------------------------------|------------------|------------|--------------|-----------------|
| Weck Auto Endo5®
Hem-o-lok® Ligating Clip
Applier | Teleflex Medical | K152081 | FZP | 08/26/2015 |
F. Comparison To Predicate Devices
The proposed Auto Endo5 5mm Automatic Endoscopic 35cm Applier is substantially equivalent to the predicate device with respect to technology, intended use, indications, and functional characteristics. The modifications proposed within this submission are minor changes that align to the original device design intent and do not introduce any new issues of safety and effectiveness.
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G. Device Description
The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
H. Indications for Use
The Weck Auto Endo5® Hem-o-lok® ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok® ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
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 to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
. 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.
J. Environmental Conditions
Hem-o-lok Ligating Clips are "MR Safe" and pose no known hazards in MR environments, as cleared under K133202, December 2013.
K. Materials
All patient contacting materials are equivalent to the predicate, including those with indirect patient contact, and are in compliance with ISO 10993-1 according to their nature and duration of contact.
L. Technological Characteristics
A comparison of the technological characteristics of the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier and the predicate has been performed. The results of this comparison demonstrate that the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is equivalent to the marketed predicate device.
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M. Performance Data
Non-clinical performance testing has been conducted following product sterilization, environmental conditioning, and simulated distribution in order to support device modifications and ensure the device performed equivalently to the predicate.
Usability and design validation of the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier in a simulated use environment was conducted to document that the user was able to operate the system as intended, and the product conformed to user needs.
N. Conclusion
Based upon the performance and comparative test results, the proposed Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is substantially equivalent in performance to the predicate device cleared to market via 510(k) K152081. The modifications made to the Auto Endo5® 5mm Automatic Endoscopic 35cm Applier do not introduce any new issues of safety and effectiveness.