(39 days)
No
The device description details a mechanical suction and cutting system for obtaining biopsy specimens. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended to obtain biopsy specimens for diagnostic purposes, not to treat a disease or condition.
Yes
The device is intended to obtain biopsy specimens for the pathological examination and diagnosis of Hirschsprung's disease, which falls under diagnostic purposes.
No
The device description clearly details physical components like a capsule, handpiece, blade, seal, syringe, and tubing, indicating it is a hardware-based medical device.
Based on the provided information, the RB12 Suction Rectal Biopsy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens outside the body. They analyze samples like blood, urine, or tissue to provide information about a patient's health.
- The RB12 is a device used within the body to obtain a specimen. Its primary function is to collect a tissue sample (biopsy) from the rectal mucosa and submucosa.
- The pathological examination of the collected specimen is the IVD step. The RB12 facilitates this process by providing the sample, but it is not the device that performs the diagnostic analysis.
Therefore, the RB12 is a surgical or procedural device used for tissue acquisition, not an IVD device.
N/A
Intended Use / 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.
Product codes
FCK
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal mucosa and submucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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
Bench testing was performed including a seal test, a chisel blade test, and an assembled capsule test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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: 727-797-4727 Fax: 727-797-4757 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
| 2519 McMullen Booth Road | t 727 797 4727 | E-mail: info@emergogroup.com |
|---|---|---|
| Suite 510-295 | f 727 797 4757 | 'Website: www.emergogroup.com |
| Clearwater, FL 33761 USA | ||
| 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 |
1
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
SBT-100
K902097 | Proposed Device
Aus systems - RBI2 |
|-------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------|
| Handpiece for instrument placement | ✓ | ✓ |
| Cylindrical tube housed within handpiece | ✓ | ✓ |
| Cylindrical tube distal end connects to
closed end capsule | ✓ | ✓ |
| Capsule has side port to allow specimen to
be sucked into capsule under negative
pressure | ✓ | ✓ |
| Aspiration connection to cylindrical tube | ✓ | ✓ |
| Internal blade to cut tissue whilst under
negative pressure | ✓ | ✓ |
| Pressure seal mechanism | ✓ | ✓ |
| Trigger to activate blade | ✓ | ✓ |
| Insertion depth measurement indicators | ✓ | ✓ |
| Intended use | Rectal biopsy specimen
collection | Rectal biopsy
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 |
2
| Target population | Trained physician | Trained physician |
|---|---|---|
| Visualization techniques | Insertion depth markers | |
| on outer surface | Insertion depth | |
| markers on outer | ||
| surface | ||
| Method of placement | Port side Posteriorly | |
| within the rectum | Port side Posteriorly | |
| within the rectum 1- | ||
| 5cm | ||
| Reusability | All parts reusable | Reusable handpiece, |
| disposable (single | ||
| 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
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
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.
Image /page/3/Picture/9 description: The image shows a circular logo with the text "FDA Centennial 1906-2006" in it. The logo is black and white and has a vintage look. The text is arranged in a circular pattern around the central "FDA" abbreviation. There are also three stars at the bottom of the logo.
Protecting and Promoting Public Health
4
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 (800) 638-2041 or (240) 276-3150
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
5
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.