K Number
K051301
Device Name
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
Date Cleared
2005-08-30

(103 days)

Product Code
Regulation Number
878.4750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Device Description
The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is available in a 33mm diameter size only. The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).
More Information

PPH03

Not Found

No
The summary describes a mechanical surgical stapler and does not mention any AI/ML terms or functionalities.

Yes
The device is used to perform surgical treatment of hemorrhoidal disease, which is a therapeutic intervention.

No
This device is a surgical stapler used for the treatment of hemorrhoidal disease, which is a therapeutic rather than a diagnostic function.

No

The device description clearly describes a physical surgical stapler, which is a hardware device, 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 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 description details a surgical stapler used for a specific surgical technique (PPH).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention.

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 (PPH03) is available in a 33mm diameter size only . The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories

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

510(k) Summary

CompanyEthicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, OH 45242
  • Kimberly McCoy, RAC Contact Regulatory Affairs Associate I Telephone: (513) 337-7266 (513) 337-1444 Fax: Email: kmccoy(@eesus.jnj.com
    Date Prepared May 18, 2005

Device Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories Classification Name: Implantable Staples {21 CFR 878.4750 (GDW)]

PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories Predicate Device

The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is Device Description available in a 33mm diameter size only . The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

Indications for Use The PROXIMATE PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The following contraindications for PROXIMATE PPH Contraindications Hemorrhoidal Circular Stapler have been added to the labeling (package insert):

  • Do not use the instrument for full rectal wall resection. .
  • Do not use the instrument for the Stapled Transanal Rectal Resection . (STARR) procedure.

Technological and Performance Characteristics The technological and performance characteristics of the device remain unchanged ..

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white.

AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kimberly McCoy, RAC Regulatory Affairs Associate I Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K051301

K01301
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: August 8, 2005 Received: August 9, 2005

Dear Ms. McCoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(s) pe device is substantially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate Tor use stated in the encrosule) to 1976, the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, is excordance with the provisions of the Federal Food, DINEA devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Ac. (71ct) market the device, subject to the general controls provisions of the Act. The You may, dicierore, market the as rees, polyde requirements for annual registration, listing of general condols provisions of ractice, 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to basil adala academians, Title 21, Parts 800 to 898. In addition, FDA may be found inther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Trass oc advised that I Drivisant that your device complies with other requirements of the Act mat I Dri has made a aond regulations administered by other Federal agencies. You must of ally it cochar statutes and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

2

Page 2- Ms. Kimberly McCoy, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to oegin maxioning of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific acres at (240) 276-0115. Also, please note the regulation entitled, Colliact the Ories of Compuners of the Researce (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response 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,
Barbara Buehnd
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KOS 130)

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

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Saubare Buehnd forsmxm

Division of General, Restoration. and Neurological Devices

510(k) Number K051301