(28 days)
Not Found
No
The description focuses on the mechanical function and material properties of the clip and delivery system, with no mention of AI or ML.
Yes
The device is indicated for medical purposes such as hemostasis, treating lesions, and closure of GI tract luminal perforations, all of which aim to treat or alleviate a disease or injury.
No
The provided text clearly states the device's indications for use are for tissue compression, hemostasis, treating lesions, endoscopic marking, and closure of perforations. These are all therapeutic or interventional actions, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly details a physical ligation clip made of shape memory alloy and a flexible delivery system with a hand control, indicating it is a hardware device.
Based on the provided information, the Padlock Clip™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Padlock Clip™ is a surgical/therapeutic device used within the body to treat conditions in the gastrointestinal tract.
- The intended use and device description clearly outline a mechanical function for tissue manipulation, hemostasis, and closure of perforations. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies focus on mechanical and biological safety aspects of the device itself (cytotoxicity, tensile strength, etc.), not on the accuracy of diagnostic results from analyzing samples.
Therefore, the Padlock Clip™ falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the gastrointestinal organs.
The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- · Endoscopic marking of lesions
- · Hemostasis for:
- o Mucosal/Submucosal defects
- o Bleeding Ulcers
- o Arteries
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
April 12, 2018
STERIS Corporation Tony Piotrkowski Senior Regulatory Affairs Manager 5976 Heisley Road Mentor. OH 44060
Re: K180689
Trade/Device Name: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: March 14, 2018 Received: March 15, 2018
Dear Tony Piotrkowski:
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.
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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 803); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, but it is mostly covered by the text.
Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180689
Device Name
Padlock Clip defect closure device Padlock Clip Pro-Select defect closure device
Indications for Use (Describe)
The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the gastrointestinal organs.
The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- · Endoscopic marking of lesions
- · Hemostasis for:
- o Mucosal/Submucosal defects
- o Bleeding Ulcers
- o Arteries 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."
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Image /page/3/Picture/0 description: The image shows the logo for TERIS, with the registered trademark symbol next to it. Below the logo is a graphic of several blue horizontal lines. In the upper right corner of the image, the text "K180689 Page 1 of 5" is visible.
510(k) Summary For Padlock Clip Pro-Select™ defect closure device and Padlock Clip™ defect closure device
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Anthony Piotrkowski Contact: Senior Regulatory Affairs Manager Tel: 440-392-7458 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com
Summary Date: April 11, 2018
Premarket Notification Number: K180689
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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K180689 STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure devices
1. Device Name
| Trade Name: | Padlock Clip defect closure device
Padlock Clip Pro-Select defect closure device |
|------------------------|-------------------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Ligator clip |
| Classification Name: | Hemorrhoidal ligator |
| Classification Number: | 21 CFR 876.4400 |
| Product Code: | PKL |
2. Predicate Device
K120814 Aponos Medical, Padlock Clip
3. Description of Device
The Padlock Clip™ ligation clip consists of a preloaded, radiopaque, single use, coin sized ligation clip made of superelastic shape memory alloy for tissue approximation with opening sizes of 6 to 24mm on a flexible delivery system.
4. Intended Use
The Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- · Endoscopic marking of lesions
- · Hemostasis for:
- o Mucosal/Submucosal defects
- o Bleeding Ulcers
- o Arteries