SAPIMED DISPOSABLE SIGMOIDOSCOPE

K070915 · Sapimed S.P.A. · KDM · Jul 6, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070915
• Device Name: SAPIMED DISPOSABLE SIGMOIDOSCOPE
• Applicant: Sapimed S.P.A.
• Product Code: KDM · Gastroenterology, Urology
• Decision Date: Jul 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.

Device Story

Disposable sigmoidoscope/proctoscope system; consists of multi-use plastic grip and single-use insertion tubes with matching obturators. Grip connects to external light source (fiberoptic or pen-light) and features posterior hinged closure with lens and insufflator attachment. Insufflator uses manual squeeze ball with one-way valve. Used by trained medical personnel in clinical settings for rectal/lower bowel examination and diagnostic/therapeutic procedures. Provides visual access to lower GI tract; facilitates atraumatic insertion via obturator. Benefits include reduced cross-contamination risk via single-use tubes.

Clinical Evidence

No clinical data. Evidence limited to bench testing, including accelerated aging testing for 5-year shelf life and biocompatibility testing per ISO 10993 standards.

Technological Characteristics

Plastic construction; rigid insertion tube with obturator; manual insufflation via squeeze ball; fiberoptic or pen-light illumination; non-sterile (A.4113, A.4120, A.4125) or sterile (A.4522) configurations.

Indications for Use

Indicated for medical personnel trained in proctology procedures to examine the rectum and lower bowel and perform diagnostic or therapeutic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Welch Allyn, Inc Disposable Sigmoidoscope Model#53125 (K770291)

Submission Summary (Full Text)

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510(k) Summary

K070915

pg 1 of 2

SAPIMED S.P.A. Via Santi 25-Z.I. D4 Scalo Alessandria, ITALY 15100 Phone [phone]

JUL - 6 2007

Contact: Mrs. Paola Oddenino

Summary Prepared: February 28, 2007

Trade Name: Disposable Sigmoidoscope/

Common Name: Disposable Sigmoidoscope/Proctoscope

Classification Name: Endoscope And/Or Accessories

Predicate Device Identification:

CFR21:876.1500 Product Code:KOG Device Class:II Legally Marketed Device: Company Product 510(k) # Welch Allyn, Inc Disposable Sigmoidoscope Model#53125 K770291

#### Description:

The Proctoscopy set consists of a multi-use plastic Grip (Ref. A.4131) and a choice of 3 different single use Insertion Tubes (Ref. A.4113, A.4120, A.4125). Each insertion tube comes with a matching obturator to facilitate the atraumatic insertion of the tube into the rectum.

The multi-use plastic Grip (Ref. A.4131) consists of the following elements:

1. A hollow handle designed to connect to the light source (either a fiberoptic cable or a pen-light).

2. A circular frontal opening designed to connect to the Insertion Tube.

3. A posterior hinged closure containing both the lens and the insufflator attachment.

The insufflator is a hand squeeze ball with a one-way valve as also used in manual blood pressure measuring devices.

The Sigmoidoscope Kit MRP (ref. A.4522) consists of a Rigid Proctosigmoidoscope insertion tube and a plastic grip.

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K 070915
pg 2 of 2

Sapimed Sigmoidoscopes are intended for exclusive use by medical personnel trained in proctology procedures.

#### Intended Use:

SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.

### Predicate Product Comparison Chart:

| Parameter | | |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Disposable<br>Sigmoidoscope/Sigmoidoscope | Welch Allyn Disposable sigmoidoscope |
| Product Code | KOG | KOG |
| K Number | | K770291 |
| Common<br>Name | Disposable Sigmoidoscope | Disposable sigmoidoscope |
| Intended Use | SAPIMED's Sigmoidoscopes are used to<br>examine the rectum and lower bowel<br>and, using additional accessories,<br>perform various diagnostic and/or<br>therapeutic procedures. | SAPIMED's Sigmoidoscopes are used to<br>examine the rectum and lower bowel and,<br>using additional accessories, perform<br>various diagnostic and/or therapeutic<br>procedures. |
| Material | Plastic | plastic |
| Single use | Yes | Yes |
| A.4113, | Clean, non-sterile | Clean, non-sterile |
| A.4120, | | |
| A.4125 | | |
| A.4522 | Sterile | |
| Sigmoidoscope | | |
| Kit MRP | | |

# Similarities and differences between Sapimed Disposable Sigmoidoscope and Predicate Products

The Sapimed disposable sigmoidoscopes have a similar intended use, technological

characteristics and mode of operation as the predicate products, both disposable and

reuseable and presents no new questions concerning safety and efficacy.

## Shelf Life

Accelerated aging testing was performed to substantiate an expiration of 5 years.

## Biocompatibility Testing:

ISO10993 standards

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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is drawn with thick, black lines and has a simple, abstract design.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

2007

SAPI Med S.p.A. c/o Ms. Yolanda Smith Smith & Associates Consultants 1676 Village Green, Suite A CROFTON MD 21114

Re: K070915

> Trade/Device Name: Sapimed Disposable Sigmoidoscope Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KDM Dated: June 1, 2007 Received: June 4, 2007

Dear Ms. Smith:

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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large, stylized "FDA" with the word "Centennial" underneath. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial anniversary of the Food and Drug Administration.

wing and Promoting Publio Goalth

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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); 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.

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 21 CFR 884.xxxx 21 CFR 892.xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 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/cdrh/industry/support/index.html

<http://www.fda.gov/cdrn/industry/support/index.html>

Sincerely vours.

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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# Indications for Use

510(k) Number (if known): __ K 0709 / S

Device Name: Sapimed Disposable Sigmoidosocope

Indications for Use:

SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulul Rusu noz
(Division Sign Off)

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