The Boehringer Laboratories Gastric Sizing Tube is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Device Description

The Boehringer Laboratories Gastric Sizing Tube is a single patient use, non-sterile device which consists of a 76 cm long, thermoplastic elastomer (Styrene-Ethylene-Styrene) tube of either 32 French, 36 French, or 40 French diameter, with a low density polyethylene (LDPE) slide valve-connector at the proximal end of the tube. The tube has multiple holes and a rounded end, distal from the slide valve, and contains a stainless steel support spring inside the lumen of the tube at the distal end. The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The slide valve is used to switch between open for suction/irrigation and closed/vent. The tube serves as a sizing guide.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Boehringer Laboratories Gastric Sizing Tube, focusing on the acceptance criteria and the study (or lack thereof) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily focused on equivalence to predicate devices and adherence to established standards for medical devices and biocompatibility. The performance reported is that the device meets or exceeds these criteria, primarily through non-clinical bench testing.

Acceptance Criterion	Description	Reported Device Performance
Equivalence to Predicate Devices	The device must demonstrate substantial equivalence in intended use, technological characteristics, safety, and effectiveness to predicate devices.	Stated to be "as safe, as effective, and performs as well as the predicate devices."
Dimensional Analysis	Verification of physical dimensions (e.g., length, diameter).	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
Valve-Connector to Tube Joint Strength	Testing the integrity and strength of the connection between the valve-connector and the tube.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
Tube Distal End Kink Test	Assessment of the tube's resistance to kinking at its distal end.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices." (Note: The device also has an internal support spring for increased resistance to kinking).
Support Spring to Tube Stability Test	Evaluation of the stability and integration of the internal support spring within the tube.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
Age Test	Assessment of the device's performance and integrity over time or simulated aging.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
ISO 80369-1:2010 Compliance	Compliance with general requirements for small-bore connectors for liquids and gases in healthcare applications.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
Suction Tubing Fitting Connector Test	Verification of the integrity and functionality of the suction tubing fitting connector.	Performance testing "indicates the new device performs equivalently to, or better than the predicate devices."
Cytotoxicity (ISO 10993-5)	Evaluation of the potential for the device's materials to cause cell damage or death.	Conducted, indicating biocompatibility.
Intracutaneous study (ISO 10993-10)	Assessment of irritation potential when in contact with tissue.	Conducted, indicating biocompatibility.
Maximization Sensitization (ISO 10993-10)	Evaluation of the potential for the device's materials to cause allergic sensitization.	Conducted, indicating biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each non-clinical test. The tests are described as performance testing and primarily involve bench testing of the device itself (e.g., dimensional analysis, strength tests).
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or engineering setting, not on patients. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective). The studies are inherent to the device's design and manufacturing process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable to this 510(k) submission. The "ground truth" for the non-clinical performance tests is based on engineering specifications, recognized international standards (like ISO 80369-1, ISO 10993-5, ISO 10993-10), and comparisons to predicate device characteristics. There's no mention of expert consensus required to establish the truth for, for example, a tube's burst strength or material biocompatibility, as these are objectively measurable against defined standards.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication typically refers to expert review in clinical studies to resolve disagreements in interpretations or diagnoses. Here, the testing is objective and based on engineering and biocompatibility standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study evaluates how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance, which is not relevant for a gastric sizing tube. The submission is for a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone (algorithm only) study was not done. This device is a physical, non-AI medical instrument. The concept of an "algorithm only" performance study is not applicable here.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is derived from:
- Engineering Specifications: Designed physical boundaries and performance targets for the device.
- International Standards: Compliance with recognized standards such as ISO 80369-1 for connectors and ISO 10993 series for biocompatibility.
- Predicate Device Characteristics: The characteristics of the legally marketed predicate devices serve as a benchmark for equivalence in terms of function and safety profile.

8. The Sample Size for the Training Set

This section is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” that proves the device meets the acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing. This testing demonstrates that the Boehringer Laboratories Gastric Sizing Tube's physical and material properties meet established engineering standards, regulatory requirements, and are comparable to (or better than) the predicate devices it claims substantial equivalence to.

The non-clinical tests included:

Dimensional Analysis
Valve-Connector to Tube Joint Strength Test
Tube Distal End Kink Test
Support Spring to Tube Stability Test
Age Test
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General Requirements Compliance
Suction Tubing Fitting Connector Test

Additionally, biocompatibility studies were conducted:

Cytotoxicity study per AAMI/ANSI/ISO 10993-5: 2009
Intracutaneous study per AAMI/ANSI/ISO 10993-10: 2010
Maximization Sensitization study per AAMI/ANSI/ISO 10993-10: 2010

The conclusion states that based on the intended use, technological characteristics, and performance testing, the device is "as safe, as effective, and performs as well as the predicate devices," thereby meeting the criteria for substantial equivalence.

Summary

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4. 510(k) Summary

Prepared: February 11, 2013

APPLICANT INFORMATION:

MAR 2 8 2013

Name: Address:

Boehringer Laboratories, Inc. 300 Thoms Drive Phoenixville, PA 19460

ﺮ ﺑ

Phone: Fax: Contact: 610-278-0900 610-278-0907 Christopher Radl; Engineering, Product Development Manager

Signature:

TRADE NAME:

Boehringer Laboratories Gastric Sizing Tube

COMMON NAME:

Gastrointestinal Tube and accessories

DEVICE CLASSIFICATION:

Class II Product Code: KNT Requlation: 876.5980 Classification Panel: General & Plastic Surgery

PREDICATE DEVICES:

REALIZE™ Gastric Calibration Tube EndoFLIP® Gastric Tube EF-900

K071764 K110529

DEVICE DESCRIPTION:

The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The slide valve is used to switch between open for suction/irrigation and closed/vent. The tube serves as a sizing guide.

INTENDED USE:

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COMPARISON SUMMARY

・・

Device	Boehringer Laboratories GastricSizing Tube	Predicate REALIZET™ GastricCalibration Tube K071764	Predicate EndoFLIP® Gastric TubeEF-900 K110529
Manufacturer	Boehringer Laboratories	Obtech Medical Sarl / Ethicon Endo-Surgery Inc	Crospon
Intended Use
Indications forUse Statement	The Boehringer Laboratories GastricSizing Tube is indicated for use ingastric and bariatric surgicalprocedures for the application ofsuction, stomach decompression,drainage of gastric fluids, irrigationand to serve as a sizing guide.	The Gastric Calibration tube isindicated for use in gastric andbariatric surgical procedures toprovide visible and tactile delineationof the antrum of the stomach alongwith the ability to decompress thestomach, drain and remove gastricfluid and size a gastric pouch.	The EndoFLIP® EF-900 GastricTube is intended for use in bariatricsurgical procedures to provide asized support bougie, and to permitstomach decompression, gastricfluid drainage and removal. It is alsointended for use to aid deploymentof EndoFLIP® EF-620, EF-325 andB-325 catheters.
Typical Use	Gastric and bariatric procedures	Gastric and bariatric procedures	Gastric and bariatric procedures
Environments ofUse	Surgery centers, hospitals	Surgery centers, hospitals	Surgery centers, hospitals
Patient Population	Individuals undergoing bariatricand/or gastric procedures	Individuals undergoing bariatricand/or gastric procedures	Individuals undergoing bariatricand/or gastric procedures
Intraoperative Use	Yes	Yes	Yes
Functions	Suction, drainage, sizing, irrigation	Suction, drainage, sizing, irrigation	Suction, drainage, sizing, irrigation,deployment of EndoFLIP® catheter
Technical/Performance Characteristics
Outer Diameter /French size	32F, 36F, or 40F	38F	43F
Length	76 cm	74.5 cm	75 cm
Tubing	Single lumen with rounded, closeddistal end	Single lumen with rounded, closeddistal end	Single lumen with open distal end
Distal Side Holes	Yes	Yes	Yes
Connector forSuction	Yes	No	Yes
Slide Valve	Yes	No	No
Balloon + InflationValve	No	Yes	No
Tubing Material	Styrene-Ethylene-Butylene-Styrene(SEBS Co-polymer)	Silicone	PVC with Duraglide PTFE coating
Markings	No markings.	Markings are provided with the zeroreference located approximately 40cm from the proximal end of theballoon.	Includes a mark at 20 cm and 70 cmfrom the distal end.
Sterility	Supplied non-sterile, disposable,single patient use	Supplied non-sterile, disposable,single patient use	Supplied non-sterile, disposable,single patient use

PERFORMANCE/NON-CLINICAL TESTING:

The following non-clinical performance testing has been submitted, referred to, or relied on in this 510k submission:

. Dimensional Analysis
. Valve-Connector to Tube Joint Strength Test
. Tube Distal End Kink Test
Support Spring to Tube Stability Test .
. Age Test
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part � 1: General Requirements Compliance
. Suction Tubing Fitting Connector Test

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Cytotoxicity study per AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices . Part 5: Tests for in vitro cytotoxicity.
Intracutaneous study per AAMI/ANSI//SO 10993-10: 2010 Biological Evaluation of Medical . Devices Part 10: Tests for irritation and skin sensitization.
. Maximization Sensitization study per AAMI/ANSI/ISO 10993-10: 2010 - Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization.

DISCUSSION:

The Boehringer Laboratories Gastric Sizing Tube is similar to the predicate devices REALIZE™ Gastric Calibration Tube and EndoFLIP® Gastric Tube EF-900.

Intended Use

The indications for use statement for the Boehringer Laboratories Gastric Sizing Tube contains language that is not specifically incorporated in the indications for use statements of the predicate device. Specifically the Boehringer Laboratories Gastric Sizing Tube indication for use statement includes "for the application of suction" and "irrigation".

While the exact text "for the application of suction" is not specifically included in the Indications for Use statements of the predicate devices it is inherent in the functions of stomach decompression and removal of gastric fluid, which are included in the indication for use statements of the predicate devices. Additionally, suction is referred to in the description section of the 510k Summary for the REALIZE™ Gastric Calibration Tube and the description section of the REALIZE™ Gastric Calibration Tube Instructions for Use, as well as in the Device Description section of the EndoFLIP® Gastric Tube EF-900 510k summary.

While "irrigation" is not specifically included in the Indications for Use statements of the predicate devices, it is specifically covered in the Description Section of the 510k Summary for the REALIZE™ Gastric Calibration Tube and the Description Section of the REALIZE™ Gastric Calibration Tube Instructions for use, as well as in the Device Description section of the EndoFLIP® Gastric Tube EF-900 510k summary.

As such, these differences do not affect the safety and effectiveness of the new device when used as labeled.

Technical Characteristics

The Boehringer Laboratories Gastric Sizing Tube has technological characteristics similar to the predicate devices. The tubes are made from different materials, however, the materials of the Boehringer Laboratories Gastric Sizing Tube and the predicate devices are all biocompatible. The Boehringer Laboratories Gastric Sizing Tube includes a slide valve, while the predicate devices do not. The slide valve enables the user to more easily turn suction on and off. The predicate devices include markings on the tube, while the Boehringer Laboratories Gastric Sizing Tube does not, as it is inserted under laparoscopic visualization. Lastly, the Boehringer Laboratories Gastric Sizing Tube includes an internal support spring at the distal end which provides the device with increased resistance to kinking. These differences do not affect the safety and effectiveness of the new device when used as labeled.

Performance Testing

The performance testing conducted with the Boehringer Laboratories Gastric Sizing Tube referenced above indicates the new device performs equivalently to, or better than the predicate devices.

CONCLUSION:

As evidenced from the intended use, technological characteristics, and performance testing conducted, the Boehringer Laboratories Gastric Sizing Tube is as safe, as effective, and performs as well as the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2013

BOEHRINGER LABORATORIES, INC. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K130483

Trade/Device Name: Boehringer Laboratories Gastric Sizing Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 14, 2013 Received: March 15, 2013

Dear Mr. Job:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

HerbertP.Lerner-S

Acting Director for: Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indications for Use Form

510(k) Number (if known): _ K130483

Device Name: Boehringer Laboratories Gastric Sizing Tube Indications for Use:

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/9 description: The image shows the text "Herbert P. Lerner -S" in a simple, sans-serif font. The text is arranged horizontally, with the name "Herbert P. Lerner" appearing prominently. The "P." is stylized with a circular design around it. The "-S" is smaller and slightly offset to the right of the name.

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130483 510(k) Number _

Regulation Number and Section

§ 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.