(41 days)
No
The summary describes a mechanical surgical stapler and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical stapler used to perform a surgical treatment, specifically resecting a segment of tissue and applying staples. It is an instrument for a surgical procedure, not a therapeutic device designed to treat a condition through non-surgical means or deliver therapy.
No
Explanation: The device is a surgical stapler used for treatment of hemorrhoidal disease and tissue resection, not for diagnosing conditions.
No
The device description clearly states it is a "set of instruments" and describes mechanical actions like "delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform surgical treatment of hemorrhoidal disease within the anal canal. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical stapler used to cut and staple tissue. This is a surgical instrument, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the body to provide diagnostic information.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Product codes
GDW
Device Description
The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids, from which the name of the modified device is derived.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal
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
Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories (K991030)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03)
510(k) Summary of Safety and Effectiveness
MAR 2 0 2003
Company:
Ethicon Endo-Surgery. Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact:
Name: Carol Sprinkle Title: Regulatory Affairs Specialist
Date Prepared:
February 6, 2003
Name of Device:
Trade Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Common Name: Intraluminal Stapler (ILS) Classification Name: Implantable Staple, General & Plastic Surgery Surgical Device
Predicate Device:
PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories (K991030).
Device Description:
The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids, from which the name of the modified device is derived.
Indications for Use:
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Technological Characteristics:
The PROXIMATE PPH Hemorrhoidal Circular Stapler is similar to the predicate device, in that it is a single-use sterile device with the same intended use and basic technology.
Performance Data
Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three faces in profile, arranged in a row. The figure is black and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure.
Public Health Service
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K030411
Trade/Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 6, 2003 Received: February 7, 2003
Dear Ms. Sprinkle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Carol Sprinkle
This letter will allow you to begin 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mulkeran
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page __ of __ __ _
510(k) Number (if known): KO30411
Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories
Indications for Use:
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Mark N. Milken
Division Sign-Off Division of General, I revocative and Neurological Devices
510(k) Number -
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)