(27 days)
No
The description focuses on the mechanical aspects of a ligation clip and its delivery system, with no mention of AI or ML capabilities.
Yes
The Padlock Clip™ is indicated for several therapeutic uses, including hemostasis, treating lesions, and closure of GI tract luminal perforations, which are direct medical interventions to treat conditions.
No
The device is described as an endoscopic clip used for mechanical actions like tissue compression, marking, hemostasis, and closure of perforations, not for diagnosing conditions.
No
The device description clearly details a physical ligation clip made of shape memory alloy and a flexible delivery system with a hand control. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Padlock Clip™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Padlock Clip™ Function: The Padlock Clip™ is a medical device used within the body (in vivo) during flexible endoscopy procedures. Its purpose is to physically manipulate and compress tissue for hemostasis, lesion treatment, marking, and perforation closure. It does not analyze or test biological specimens.
The description clearly outlines a device used for direct intervention and manipulation of tissue within the gastrointestinal tract, which is the opposite of an in vitro diagnostic function.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
October 24, 2019
STERIS Corporation Tony Piotrkowski Regulatory Affairs Director 5960 Heisley Road Mentor, OH 44060
Re: K192722
Trade/Device Name: Padlock Clip Pro-Select™ defect closure system, Padlock Pro-Select™ defect closure device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 26, 2019 Received: September 27, 2019
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. 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.
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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 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 (QS)
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 medical devices and radiation-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.
For Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192722
Device Name
Padlock Clip defect closure system Padlock Clip Pro-Select defect closure system
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 word STERIS in large, bold letters, with the registered trademark symbol next to it. Below the word STERIS is a graphic of several horizontal wavy lines stacked on top of each other. At the top of the image are the words "K192722" and "Page 1 of 5".
510(k) Summary For Padlock Clip Pro-Select™ defect closure system and Padlock Clip™ defect closure system
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Anthony Piotrkowski Regulatory Affairs Director Tel: 440-392-7458 Fax: 440-357-9198 Email: tony_piotrkowski@steris.com
Summary Date: September 26, 2019
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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STERIS Special 510(k) PREMARKET NOTIFICATION Modification to Padlock Clip and Padlock Clip Pro-Select defect closure systems
1. Device Name
| Trade Name: | Padlock Clip defect closure system and
Padlock Clip Pro-Select defect closure system |
|------------------------|-----------------------------------------------------------------------------------------|
| 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
| K180689 | Padlock Clip defect closure device and Padlock Clip Pro-Select defect closure device |
|---|---|
| --------- | -------------------------------------------------------------------------------------- |
Originally cleared as:
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