HEMORPEX SYSTEM

K090432 · Angiologica B. M. Srl · FER · May 29, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090432
• Device Name: HEMORPEX SYSTEM
• Applicant: Angiologica B. M. Srl
• Product Code: FER · Gastroenterology, Urology
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.

Device Story

HemorPex System (HPS) is a disposable anoscope for surgical treatment of hemorrhoidal disease via dearterializing hemorrhoidopexy. Device consists of a fixed part contacting the anoderma/anal mucosa and a rotating operative part with a window for suture placement. Features 6 preset window positions corresponding to the 6 terminal branches of the superior hemorrhoidal artery. Used by physicians in clinical settings to visualize the anal canal and facilitate surgical access. Output is direct visualization and physical access for suturing; assists in targeted dearterialization to treat hemorrhoids.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Disposable anoscope; plastic construction; single-use; sterile; 6-position rotating operative window for surgical access; manual operation.

Indications for Use

Indicated for physician use to examine the anal sphincter and anus and to perform diagnostic and therapeutic procedures, including surgical treatment for hemorrhoidal disease.

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

• SAPIMED DISPOSABLE ANOSCOPE (K070913)

Submission Summary (Full Text)

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# Kogo432

### 510(k) Summary

MAY 2 9 2009

### Official contact:

### ANGIOLOGICA B.M. S.r.l.

Via Giovanni XXIII, 4 - 27028

San Martino Siccomario (PV) - Italy contact person: Roberto Manca telephone: [phone] fax number: [phone] e-mail: [e-mail] Date: 18/02/2009

Trade names:

HEMORPEX SYSTEM (HPS):

Common name:

DISPOSABLE ANOSCOPE

Classification name:

ANOSCOPE AND ACCESSORIES

Predicate devices:

The HEMORPEX SYSTEM (HPS) - produced by ANGIOLOGICA B.M. S.r.I. - is substantially equivalent to the SAPIMED DISPOSABLE ANOSCOPE.

Description:

HEMORPEX SYSTEM (HPS) is a diagnostic and operating anoscope, which is mainly intended for the surgical treatment of the hemorrhodal disease through dearterializing hemorrhoidopexy.

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HemorPex System (HPS) is a device made by a fixed part which remains in contact with the anoderma and the sensible mucosa of the anal canal, and by a rotating operative part which includes the window through which the suture stitches are posed.

The instrument has 6 preset positions of the operative window. In these positions there are the 6 terminal branches of the superior hemorrhoidal artery.

Intended use:

The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.

Comparison to predicate devices:

The HEMORPEX SYSTEM (HPS) have the same intended use, the same farget population, the same kind of contact and the same technological characteristics (materials, sterility, general shape).

| DEVICE NAME | ANGIOLOGICA | PREDICATE DEVICE |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PRODUCT CODE | HEMORPEX SYSTEM (HPS) | SAPIMED |
| PRODUCT CODE | FER | FER |
| K NUMBER | K090432 | K070913 |
| COMMON NAME | Disposable Anoscope | Disposable Anoscope |
| INTENDED USE | The HEMORPEX SYSTEM (HPS) is<br>intended for physician use to examine the<br>anal sphincter and anus and to perform<br>several diagnostic and therapeutic<br>procedures, such as surgical treatment for<br>hemorrhoidal disease. | Intended for physician use to<br>examine the anal sphincter and<br>anus, and, using additional<br>accessories, to perform various<br>diagnostic and therapeutic<br>procedures |
| MATERIAL | Plastic | Plastic |
| SINGLE USE | YES | YES |
| PACKAGED | Sterile | Clean, non-sterile/sterile |

Differences between ANGIOLOGICA B.M. S.r.I. HEMORPEX SYSTEM (HPS) and the predicate device should not affect the safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 9 2009 MAY

Mr. Roberto Manca Quality Manager Angiologica B.M. s.r.l. . 4 Via Giovanni XXIII San Martino Siccomario (PV) 27028 ITALY

Re: K090432

Trade/Device Name: Hemorpex System (HPS) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: May 5, 2009 Received: May 6, 2009

Dear Mr. Manca:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

[phone] [phone] [phone] [phone]

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

Sincerely yours,

Janine M. Morris Acting 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): K090432

Device Name: HEMORPEX SYSTEM (HPS)

Indications For Use:

The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.

AND/OR Over-The-Counter Use Prescription Use N/A (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of QDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

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