RB12 SUCTION RECTAL BIOPSY SYSTEM

K062159 · Aus Systems Pty , Ltd. · FCK · Sep 5, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062159
• Device Name: RB12 SUCTION RECTAL BIOPSY SYSTEM
• Applicant: Aus Systems Pty , Ltd.
• Product Code: FCK · Gastroenterology, Urology
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

Device Story

System comprises reusable handpiece and sterile, single-use polystyrene capsule with internal stainless steel cutting blade and polyethylene seal. Operated by physician; capsule placed against rectal mucosal wall. External syringe connected via suction tube creates negative pressure, drawing mucosal/submucosal tissue into capsule port. Thumb trigger on handpiece advances internal piston and blade, cutting tissue specimen. Airtight seal maintained during activation. Provides tissue samples for pathological examination; aids diagnosis of Hirschsprung's disease.

Clinical Evidence

No clinical data. Bench testing performed including seal test, chisel blade test, and assembled capsule test. Critical evaluation provided by pediatric surgeon.

Technological Characteristics

Materials: Polystyrene (capsule), stainless steel (blade), polyethylene (seal). Energy: Manual suction/mechanical actuation. Form factor: Handheld device with disposable capsule. Sterilization: Radiation (ISO 11137, AAMI TIR27). Standards: ISO 10993-1 (biocompatibility), ISO 7153-1 (metallic materials).

Indications for Use

Indicated for patients requiring rectal mucosal and submucosal biopsy for the diagnosis of Hirschsprung's disease.

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

• Model SBT-100 Rectal Suction Biopsy Tool (K902097)

Submission Summary (Full Text)

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## 510(k) Summary

SEP - 5 2006

### Submitter Information:

Aus Systems Pty Ltd 3 Charles Street Allenby Gardens, South Australia 5009 Australia

### Contact:

Ian P. Gordon

Telephone: [phone] Fax: [phone] email: igordon(@emergogroup.com

### Date Prepared:

July 26, 2006

### Product Name & Classification:

RBI2 Suction Rectal Biopsy System Class II, per 876.1075 Panel: Gastroenterology/Urology Product Code: FCK

### Description:

The RB12 consists of a gamma sterilized single use polystyrene closed end cylinder shaped capsule with a small hole at the closed end which contains a stainless steel cutting blade and a polyethylene seal. The capsule connects to a re-useable handpiece (HP1000) via a quick twist and lock system and suits both left and right handed operators. The HP1000 has an inner piston which automatically locates in the internal seal when the capsule is connected. This creates an airtight loop to the attached syringe via the suction tube/syringe adaptor. The inner piston is pushed forward when the thumb trigger is activated pushing the blade forward past the capsule hole cutting the specimen.

| AMERICA NO BAR<br>2519 McMullen Booth Road | t 727 797 4727 | E-mail: [e-mail] |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------|
| Suite 510-295 | f 727 797 4757 | 'Website: www.emergogroup.com |
| Clearwater, FL 33761 USA<br>НЕННИКА И ВИДИНИНИ (1912) 1912 1915 1111 1111 111 1811 1111 111 111 111 111 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 | | |

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The RBI2 design uses a combination of a re-useable handpiece and a disposable (single use) capsule. The capsule is supplied to the end users in a sterile state completely assembled with an internal blade and seal.

A syringe is connected to the rear end of the internal trigger tube via a piece of suction tube and a syringe/tube adaptor (supplied sterile with capsules). The disposable is placed onto the outer tubing that is housed within the handle. While placing the capsule the internal trigger tube automatically locates and passes through the seal. When capsule is placed onto the handpiece it creates an air loop from the syringe to the front section of the capsule. The capsule is placed against the mucosal wall of the rectum of the patient covering the capsule port. When the syringe is withdrawn this causes negative pressure in the capsule sucking the mucosal and sub mucosal into the capsule. The thumb trigger is pushed forward which pushes the blade forward cutting the tissue that has been sucked into the port. The front of the capsule remains airtight as the trigger/inner tube slides through the internal seal.

## Indications for Use:

The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

### Substantial Equivalence:

This device is substantially equivalent to the Model SBT-100 Rectal Suction Biopsy Tool, marketed under K902097 by Medical Measurements, Inc.

| Description | Predicate Device<br>SBT-100<br>K902097 | Proposed Device<br>Aus systems - RBI2 |
|-------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------|
| Handpiece for instrument placement | ✓ | ✓ |
| Cylindrical tube housed within handpiece | ✓ | ✓ |
| Cylindrical tube distal end connects to<br>closed end capsule | ✓ | ✓ |
| Capsule has side port to allow specimen to<br>be sucked into capsule under negative<br>pressure | ✓ | ✓ |
| Aspiration connection to cylindrical tube | ✓ | ✓ |
| Internal blade to cut tissue whilst under<br>negative pressure | ✓ | ✓ |
| Pressure seal mechanism | ✓ | ✓ |
| Trigger to activate blade | ✓ | ✓ |
| Insertion depth measurement indicators | ✓ | ✓ |
| Intended use | Rectal biopsy specimen<br>collection | Rectal biopsy<br>specimen collection |
| Blade size | Unknown | 5mm x 7mm |
| Insertion depth | Various | Various 1-5 cm |
| Sample notch size | 2.5mm | 2.4 - 2.7mm |
| Number of samples | multiple | 1 per capsule |
| Mode of action | Suction | Suction |

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| Target population | Trained physician | Trained physician |
|--------------------------|---------------------------------------------|-----------------------------------------------------------|
| Visualization techniques | Insertion depth markers<br>on outer surface | Insertion depth<br>markers on outer<br>surface |
| Method of placement | Port side Posteriorly<br>within the rectum | Port side Posteriorly<br>within the rectum 1-<br>5cm |
| Reusability | All parts reusable | Reusable handpiece,<br>disposable (single<br>use) capsule |

# Voluntary Standards Applied:

| ISO 13485 | Quality Systems |
|-------------|-------------------------------------------------------------------------------------|
| ISO 10993-1 | Biological Evaluation of Medical devices Part 1: Evaluation and Testing |
| ISO 11737 | Sterilization of Health Care Products - Requirements for validation and routine |
| | control -Radiation Sterilization |
| AAMI- TIR27 | Sterilization of Health Care Products - Radiation Sterilization - Substantiation of |
| | 25kGy as a Sterilization Dose - Method VD |
| ISO 11607 | Packaging for terminally Sterilized Medical Devices |
| ISO17664 | Sterilization of Medical Devices Information to be provided by the manufacturer |
| | for the processing of resterilizable medical devices. |
| ISO 7153-1 | Surgical Instruments - Metallic Materials |
| EN 1441 | Medical Device - Risk Analysis |
| EN 1041 | Medical Devices - Information supplied by Manufacturer |
| EN 980 | Graphical Symbols for Use in the Labeling of Medical Devices |

# Performance Data:

Bench testing was performed including a seal test, a chisel blade test, and an assembled capsule test.

# Critical Evaluation:

A critical evaluation of the RBI-2 device has been performed by pediatric surgeon J K Freeman, MBBS FRACS, whose credentials include the following:

- Senior Visiting Surgeon, Women's and Children's Hospital, Adelaide, South ● Australia
- Senior Lecturer in Pediatric Surgery, University of Adelaide .
- . Chief of Pediatric Surgery, Flinders Medical Center, Adelaide, South Australia
- . Senior Lecturer in Pediatric Surgery, Flinders University

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 5 2006

Re: K062159

Suite 427

Aus Systems PTY Ltd. c/o Mr. Ian P. Gordon

Senior Vice President Emergo Group, Inc.

2454 McMullen Booth Road

CLEARWATER FL 33759

Trade/Device Name: RB12 Suction Rectal Biopsy System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCK Dated: July 26, 2006 Received: July 31, 2006

Dear Mr. Gordon:

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 arior 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.

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Protecting and Promoting Public Health

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Page 2 -

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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.

Sincerely yours,

Nancy C. Hogdon

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

Finclosure

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## Indications for Use

510(k) # (if known):

Device Name: RBI2 Suction Rectal Biopsy System

Indications for Use:

The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

Prescription Use x (21 CFR 801 Subpart D) ANDIOR

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)

Daniel br. Sengrown
Division Sign Off

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