(606 days)
No
The summary describes a mechanical device for applying clips and does not mention any AI or ML components or functions.
No
The device is described as an automatic ligating clip applier for the ligation of vessels or other tubular structures, which is a surgical tool, not a therapeutic device designed for treatment or healing.
No
The device is described as an automatic ligating clip applier for "ligation of vessels or other tubular structures," which is a treatment or surgical function, not a diagnostic one. There is no mention of it being used to identify or analyze a condition.
No
The device description clearly states it is a "multiple clip applier" which is a physical, hardware device used for surgical ligation. It is not software.
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 other tubular structures." This is a surgical procedure performed in vivo (within the body) to tie off or close these structures.
- Device Description: The device is a "multiple clip applier" that applies "titanium ligating clips." This is a surgical instrument used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device and its intended use do not involve the analysis of biological specimens outside the body.
Therefore, this device is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.
The Ethicon Ligaclip Multiple Clip Appliers are instruments used for ligation of tubular structures and vessels.
Product codes
GDO, NMJ
Device Description
The reprocessed multiple clip applier is an automatic ligating clip applier. The device is preloaded with a minimum of 10 titanium ligating clips that individually advance after each clip application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or other tubular structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip appliers perform as intended and are safe and effective.
Key Metrics
Not Found
Predicate Device(s)
K771412 - Ethicon Ligaclip MCA clip appliers
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
JUL 1 1 2005
510(k) Summary
.
| Submitter: | ClearMedical, Inc.
1776 136th Place NE
Bellevue, WA 98005 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gene Lim
Ph: (425) 460-2779
Fax: (425) 401-1515 |
| Trade name: | ClearMedical Reprocessed Multiple Clip Appliers |
| Common name: | Non-reloadable Multiple Clip Appliers |
| Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Product code: | GDO - Applier, Surgical, Clip |
| Predicate device: | K771412 - Ethicon Ligaclip MCA clip appliers |
| Device description: | The reprocessed multiple clip applier is an automatic ligating clip
applier. The device is preloaded with a minimum of 10 titanium
ligating clips that individually advance after each clip application. |
| Intended use: | Reprocessed multiple clip appliers are intended for the ligation of
vessels or other tubular structures. |
| Technological
characteristics: | Reprocessed multiple clip appliers are used devices that are
cleaned, inspected, tested, packaged, and sterilized for an
additional single patient use. The technological characteristics of
design, material, and functional performance of reprocessed
multiple clip appliers are unchanged and remain equivalent to the
predicate devices. |
| Test data: | Validation of cleaning, performance, packaging, and sterilization
together with biocompatibility testing demonstrate reprocessed clip
appliers perform as intended and are safe and effective. |
| Conclusion: | Based on information provided in this submission, ClearMedical
Reprocessed Clip Appliers are substantially equivalent to the
identified predicate devices and are safe and effective for their
intended use. |
1
Image /page/1/Picture/2 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clear Medical Corporation % Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005
Re: K033579
Trade/Device Name: Reprocessed Multiple Clip Appliers Models, MCL20, MCM20, MCM30, MCS20 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NMJ Dated: July 11, 2005 Received: May 31, 2005
Dear Mr. Kovacs:
This letter corrects our substantially equivalent letter of July 11, 2005.
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 (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.
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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Mike Kovacs
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Pue Dally
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 - Mr. Mike Kovacs
Indications for Use
510(k) Number (if known): K033579
Ethicon Ligaclip Multiple Clip Appliers Device Name:
Indications for Use:
The Ethicon Ligaclip Multiple Clip Appliers are instruments used for ligation of tubular structures and vessels.
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
of Device Evaluation (ODE) Concurrence of CDRH, Off.
De of
Division of General, Restorative, and Neurological Devices
510(k) Number K033575
Page 1 of
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Page 4 - Mr. Mike Kovacs
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Device Listing:
MCL20 MCM20 MCM30 MCS20