MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS

K042659 · Medisiss · NON · Feb 14, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042659
• Device Name: MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
• Applicant: Medisiss
• Product Code: NON · Gastroenterology, Urology
• Decision Date: Feb 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 1

Intended Use

MediSISS Reprocessed Non-electric GI Biopsy Forceps are to be used during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination.

Device Story

MediSISS Reprocessed Non-electric GI Biopsy Forceps are mechanical instruments used during endoscopic procedures to retrieve tissue samples and polyps for microscopic inspection. The device consists of a distal jaw assembly (available in oval, alligator, smooth, or fenestrated configurations, with or without needle) connected to a syringe-like proximal handle. The handle allows the operator to open and close the jaws. The working length (160cm) is coated with a plastic sheath to reduce friction. The device is operated by a physician during GI endoscopy. By enabling tissue retrieval, the device assists in diagnostic pathology, allowing healthcare providers to determine the nature of polyps or lesions, thereby informing clinical management and treatment decisions.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization, functional performance, packaging, and distribution testing. Conformance to standards including ISO 11737-1, ISO 11607, ISO 11135, ISO 10993-7, and various ASTM standards (D4164, F88, F1980, F2096) was demonstrated.

Technological Characteristics

Mechanical biopsy forceps; 2.2mm-2.5mm outer diameter; 160cm working length; plastic-coated sheath. Sterilization via ethylene oxide. Conformance to ANSI/AAMI/ISO 11135, 11737-1, 10993-7; ASTM D4164, F88, F1980, F2096; ISO 11607; USP 24.

Indications for Use

Indicated for use during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination. Contraindicated when GI endoscopic procedures are contraindicated.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Bard (K912549)
• Esco Precision, Inc. (K900015)
• Olympus (K955065)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is the trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted by: MediSISS 2747 SW 6th St. Redmond, OR 97756 Telephone: [phone] Facsimile: [phone] Email: bijames(@medisiss.com September 27, 2004

FEB 1 4 2005

Contact Person Brandi James Proprietary Name MediSISS Reprocessed Non-electric GI Biopsy Forceps Common Name Reprocessed Cold GI Biopsy Forceps Classification Gastroenterology/Urology Forceps, Biopsy, Reprocessed, per 21 CFR 876.1075, Product Code: NON, Regulatory Class II.

#### Device Description and Technological Characteristics:

MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.

#### Predicate Device 510(k)s

Identification of legally marketed predicate device Original Equipment Manufacturer's 510(k)s:

| Manufacturer | 510(k)# |
|----------------------|---------|
| Bard | K912549 |
| Esco Precision, Inc. | K900015 |
| Olympus | K955065 |

Summary of Validation Data: MediSISS has validated its cleaning, sterilization, functional performance and packaging and distribution processed Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps are substantially equivalent to the new and unused predicate devices, and will continue to be safe and effective for the maximum number of intended uses.

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Image /page/1/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is a trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".

#### Standards

MediSISS Reprocessed Non-Electric GI Biopsy Forceps are either tested and/or processed in conformance with the applicable parts of the following standards:

- ANSVAAMI/ISO 11737-1-1995: Sterilization of Medical Devices-Microbiological Methods-. Part 1: Estimation of population of microorganisms on products.
- AAMI TIR No. 12-1994-Designing, Testing, and Labeling Reusable Medical Devices for t Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
- ASTM D4164: 2001 DC 13, AL 1: Performance Testing of Shipping Containers and Systems. .
- ISO 11607: 2003-Packaging for terminally sterilized medical devices. ●
- ANSI/AAMI/ISO 11135:1994, Medical devices--- Validation and routine control of ethylene oxide . sterilization.
- ANSI/AAMI/ISO 10993:1995, Biological Evaluation-Part 7: Ethylene Oxide Sterilization . Residuals.
- . ASTM F88-Seal strength of Flexible Barrier Materials.
- ASTM F1980: 2002—Standard Guide for Accelerated Aging of Sterile Medical Device Packages .
- United States Pharmacopeia 24-Sterility Test �
- ASTM F2096-02 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging ● by Internal Pressurization (Bubble Test).

#### Intended Use

MediSISS Reprocessed Non-electric GI Biopsy Forceps are to be used during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination.

#### Contraindications

The MediSISS Reprocessed Non-electric GI Biopsy Forceps should not be used when GI endoscopic procedures are contraindicated.

#### Conclusion

MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to cleanliness, sterility, design, packaging and intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 4 2005

Ms. Brandi James Regulatory Specialist MediSISS 2747 SW 6th Street REDMOND OR 97756

K042659 Re: Trade/Device Name: MediSISS Reprocessed Non-Electrical GI Biopsy Forceps (SEE ENCLOSURE) Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: I Product Code: 78 NON Dated: December 23, 2004 Received: December 27, 2004

Dear Ms. James:

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 (Premarket Approval), 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.

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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsmadsmam.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "MediSISS" in a stylized font. The word is surrounded by a black oval shape that appears to be a design element. There is a trademark symbol to the right of the word.

Surgical Instrument Service & Sterilization

Cover Letter for 510(k) Premarket Notification-MediSISS Reprocessed Non-Electric Biopsy Forceps

### INDICATIONS FOR USE

. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. דער אין א 104265 510(k) Number (if known):

Device Name: MediSISS Reprocessed Non-electric GI Biopsy Forceps

Indications for Use:

The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE OF ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

David A. Tognozzi

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(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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# 510(k) K042659: MediSISS Reprocessed Non-Electric ("Cold") GI Biopsy Forceps

The following models (and only the following models, with the descriptions below), which are the The following models (and only the tonowing models, with the associated in 1977)
subjects of this application, have been found substantially equivalent to the predicate devic listed in K042659.

| OEM Model | Description | Jaw O.D. | Length | Sheath Color |
|-------------------------|--------------------------------------------------------------|----------|--------|--------------|
| Bard 385 | Precisor* EXL Coated Biopsy Forceps, Alligator Cup | 2.3 mm | 230 cm | Blue |
| Microvasive 1537 | Radial Jaw 3 Biopsy Forcep with Needle | 2.2 mm | 240 cm | Orange |
| Microvasive 1597 | Radial Jaw, 3 Large Capacity Biopsy Forcep with Needle | 2.2 mm | 160 cm | Yellow |
| Microvasive 1599 | Radial Jaw 3, Large Capacity Biopsy Forcep with Needle | 2.2 mm | 240 cm | Orange |
| Olympus FB-240U | EndoJaw, Biopsy Forcep, Oval Cup, Fenestrated with Needle | 2.2 mm | 230 cm | Blue |
| Wilson-Cook SDE 2.5-230 | Shark Biopsy Forceps, Fenestrated without Spike (Red Handle) | 2.5 mm | 230 cm | Grey |