K Number
K953355
Device Name
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
Manufacturer
Date Cleared
1996-04-04

(262 days)

Product Code
Regulation Number
876.4300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
removal of small polyps in the GI track.
Device Description
The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.
More Information

No
The summary describes a mechanical biopsy forceps and does not mention any AI or ML components or functions.

No
The device is used for the removal of polyps, which is a surgical procedure, not a therapeutic treatment.

No

The device is described as "Hot Biopsy Forceps" used for "removal of small polyps". This indicates a therapeutic or procedural function rather than a diagnostic one. No mention of diagnosis is found.

No

The device description clearly describes a physical medical device (forceps) made of stainless steel and Teflon, intended for physical removal of polyps. It also mentions sterilization methods and working lengths, which are characteristics of hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "removal of small polyps in the GI track." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
  • Device Description: The description details a surgical instrument (forceps) used for physical removal of tissue. It doesn't mention any components or functions related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information
    • Using reagents or assays
    • Measuring analytes

The device is clearly a surgical tool used for a therapeutic intervention.

N/A

Intended Use / Indications for Use

The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.

Product codes

Not Found

Device Description

The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The GIP/Medi-Globe Hot Biopsy Forceps is designed to be used in conjunction with numerous FDA Approved endoscopes. The cleaning of the GIP/Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook Hot Biopsy Forceps. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. All materials that comprise the Hot Biopsy Forceps are similar in specification and design to the Wilson Cook Hot Biopsy Forceps. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

GI track

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

Summary data of all of the tests performed on the materials of the Hot Biopsy Forceps were tested for biological reactivity including: Implantation test, Intracutaneous test, and Systemic Injection test. In summary each test meets the requirements for biological reactivity for class VI plastics.

Key Metrics

Not Found

Predicate Device(s)

K874314

Reference Device(s)

K792215, K792267, K790071

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).

0

K953355

Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted with the requirements of SMDA 1990.

The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps.

Gastroenterology Urology biopsy through the use of a forceps is an effective, well-known and safe procedure. The GIP/Medi-Globe Hot Biopsy Forceps is designed to be used in conjunction with numerous FDA Approved endoscopes (reference Pentax's FDA registered endoscope K792215 and K792267, Olympus' endoscope K790071).

The 510(k) number for the Wilson Cook Hot Biopsy Forceps is K874314. A detailed list of GIP/Medi-Globe Hot Biopsy Forceps is presented in Exhibit D for comparison. The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track. The method of operation is the same when used in coninction with the referenced endoscopes and power supply units.

The cleaning of the GIP/Medi-Globe Hot Bionsy Forceps is identical to the Wilson-Cook Hot Bionsy Forceps. The entire device can be autoclaved or ETO gas sterilized, which are both safe, effective and widely used cleaning methods. The validation protocol for the sterilization of the Hot Biopsy Forceps is included in Exhibit C in the 510 (k) package.

The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package, similiar to the packaging of the Wilson Cook Hot Biopsy Forceps.

Summary data of all of the tests performed on the materials of the Hot Biopsy Forceps were tested for biological reactivity including: Implantation test, Intracutaneous test, and Systemic Injection test. In summary each test meets the requirements for biological reactivity for class VI plastics.

All materials that comprise the Hot Biopsy Forceps are similiar in specification and design to the Wilson Cook Hot Biopsy Forceps.

A detailed listing of both GIP/Medi-Globe's and Wilson Cook's Hot biopsy forceps' size and characteristics are included in Exhibits G and H. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300. The sizes and characteristics of the compared devices are identical with the GIP/Medi-Globe line offering a greater range.

The GIPMedi-Globe manufacturing facility has been awarded the TUV Award for Good Manufacturing (GMP) and operates in accordance with ISO

For any questions regarding the GIP/Medi-Globe biopsy forcep, please contact Gina Gallegos at (602)897-2772, 6202 S. Maple Ave, Suite 131, Tempe, AZ 85283 .