(117 days)
The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The REALIZETM Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8 cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/ or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6 cm from the proximal end of the balloon.
The provided text describes a 510(k) submission for the REALIZE™ Gastric Calibration Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (acceptance criteria, specific study details like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth methodologies) is generally not part of a 510(k) summary for a device like this.
A 510(k) summary for a relatively low-risk device like a gastric calibration tube primarily relies on:
- Comparison to predicate devices: Showing similar intended use, technological characteristics, and materials.
- Bench testing: To confirm the new device performs as intended and is equivalent to the predicate.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: REALIZE™ Gastric Calibration Tube should perform similarly to the BioEnterics® Gastric Balloon Suction Catheter and COOK® Gastric Sizing Balloon Catheter in terms of: - Gastric calibration - Visible and tactile delineation of the antrum - Decompression of the stomach - Drainage and removal of gastric fluid - Sizing of a gastric pouch - Maintenance of integrity (e.g., balloon inflation, tube strength) - Material compatibility and biocompatibility (implied by material similarity) | "Bench testing was performed to evaluate the performance of the intended use of the new device. The performance testing shows that the REALIZE™ Gastric Calibration Tube is equivalent to the BioEnterics® Gastric Balloon Suction Catheter." Specifics: - Non-sterile, single patient use. - 745 mm long silicone tube. - Approximate 38 F (12.7mm) rounded, closed tip. - Proximal end: check valve for syringe. - Balloon: 6.8 cm from distal tip. - Distal end: two suction/irrigation holes. - Reference markings on tube shaft. |
Missing Information/Not Applicable to 510(k) Summary:
- Quantified acceptance criteria (e.g., "balloon must inflate to X pressure without leakage for Y duration"). The summary only states "equivalent."
- Specific numerical performance metrics for the REALIZE™ device.
- Detailed comparison results showing how the REALIZE™ device met each implied criterion against the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. "Bench testing" generally refers to laboratory testing of physical samples, not human subjects or patient data.
- Data Provenance: Not specified, but implied to be laboratory-generated (bench testing) and not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. For bench testing of a physical device like this, "ground truth" as it relates to expert review of medical images or patient outcomes is not relevant. The "truth" is established by engineering specifications and direct physical measurements.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical endpoints in human studies. Bench testing results are typically objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. This device's performance was evaluated through bench testing, not an MRMC study.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this device does not involve AI or image interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical instrument, not an algorithm. Standalone performance refers to the performance of a software algorithm without human intervention.
7. The Type of Ground Truth Used
- For this type of device and testing, the "ground truth" would be established by engineering specifications, direct physical measurements and observations during bench testing, and potentially comparison to the known performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set for an AI/ML algorithm was used.
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510(k) Summary
UCT 2 4 2007
Company Obtech Medical Sarl Chemin-Blanc LeLocle, Switzerland CH-2400
Contact Elizabeth Miller Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7146 (513) 337-2146 Fax: Email: Imiller12@eesus.jnj.com
Date Prepared June 28, 2007
Device Name Trade Name: REALIZE™ Gastric Calibration Tube Common or Usual Name: Gastrointestinal Tubes Tubes, Gastrointestinal (And Accessories) Classification Name: [21 CFR 876.5980 (KNT)]
COOK® Gastric Sizing Balloon Catheter Predicate Device BioEnterics® Gastric Balloon Suction Catheter
Device Description The REALIZETM Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8 cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/ or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6 cm from the proximal end of the balloon.
Indications for Use The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
Technological Characteristics The REALIZE™ Gastric Calibration Tube is similar to the design, function and materials of the predicate devices BioEnterics® Gastric Balloon Suction Catheter and COOK Gastric Sizing Balloon Catheter. The REALIZE™ Gastric Calibration Tube has the same indications for use as the predicates.
Performance Data Bench testing was performed to evaluate the performance of the intended use of the new device. The performance testing shows that the REALIZE™ Gastric Calibration Tube is equivalent to the BioEnterics® Gastric Balloon Suction Catheter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. Above the caduceus are three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2007
Obtech Medical Sarl c/o Linda G. Hill, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road CINCINNATI OH 45242
Re: K071764
Trade/Device Name: REALIZE™ Gastric Calibration Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 11, 2007 Received: September 12, 2007
Dear Ms. Hill:
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 (PMA), 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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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 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.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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Indications for Use
K071764
Device Name:
REALIZE™ Gastric Calibration Tube
Indications for Use:
The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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) Page 1 of 1
(Posted November 13, 2003)
Helent Reman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.