MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.

Device Description

MIDSLEEVE™ Calibration tube for Sleeve Gastrectomy is a sterile, single use medical device which consists of a 900 mm long, silicone tube of 37.5 French diameter, with a PVC valve at the proximal end of the tube. The tube has several holes and a rounded end, distal from the valve and an asymmetric balloon which can be filled through the valve. Reference markings are provided on the tube, from the distal end to 70 cm to locate the tube position.

AI/ML Overview

The provided text is a 510(k) summary for the MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy. It discusses the device's indications for use, comparison to predicate devices, and performance testing, but it does not contain detailed acceptance criteria and a study demonstrating how the device meets that criteria in the format requested.

Specifically, the document lists "Intended performance" goals but these are qualitative statements rather than specific acceptance criteria with numerical targets. The "Performance testing" section mentions conforming to various ISO and ASTM standards and internal engineering specifications, but it does not provide the results of these tests, what specific acceptance criteria were used for each test, or how the device's performance measured against those criteria.

Therefore, for your required output, I can only extract what is mentioned in the document and note where information is missing.

Here's the breakdown of the information available in the document:

Acceptance Criteria and Study for MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy

The provided document describes "Intended performance" goals and lists various performance tests conducted. However, it does not explicitly define quantifiable acceptance criteria in a table format with corresponding reported device performance values. The document asserts that the device conforms to various standards and engineering specifications, implying successful completion of tests, but does not provide the specific data from these tests or the numerical acceptance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated as "Intended Performance" or implied by standards)	Reported Device Performance (As stated or implied in the document)
Allows intubation through the patient's mouth and down towards the stomach.	(Implied: Device design allows for this, no specific test data provided)
Allows simpler calibration of the gastric pouch during sleeve gastrectomy compared to typical method (nasogastric tube).	(Implied: Device design with balloon aims to achieve this, no specific comparative study data provided)
Dimension of preserved gastric pouch optimizes sleeve gastrectomy effectiveness (weight loss and quality of life).	(Implied: Device design aims for optimizing. No specific outcome data on weight loss or quality of life provided for this device.)
Allows combination with a suction system to drain gastric fluids and/or perform a leak test.	(Implied: Device includes features for this, e.g., "distal side holes for suction". No specific test data provided.)
Conformance to ISO 11607-01:2009 (Packaging - Part 1)	Conforms to standard. (No specific test data provided.)
Conformance to ISO 11607-01:2009 (Packaging - Part 2)	Conforms to standard. (No specific test data provided.)
Conformance to ASTM F88-09:2009 (Seal Strength)	Conforms to standard. (No specific test data provided.)
Conformance to ASTM F1980-07:2011 (Accelerated Aging)	Conforms to standard. (No specific test data provided.)
Conformance to NF EN ISO 10993-1:2010 (Biocompatibility - Part 1)	Conforms to standard; biocompatibility assessed. (No specific test data provided.)
Conformance to ASTM F1140/F1140M-13 (Internal Pressurization Failure)	Conforms to standard. (No specific test data provided.)
Conformance to NF EN ISO 10993-5:2010 (Cytotoxicity)	Conforms to standard. (No specific test data provided.)
Conformance to NF EN ISO 10993-10: 2010 (Irritation and Skin Sensitization)	Conforms to standard. (No specific test data provided.)
Dimensional Analysis (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Reliability and Safety of the Distal Balloon Inflation and Proximal Valve (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Burst Volume Testing on the Inflated Balloon (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Distal End piece Gluing Reliability (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Valve to Tube Joint Strength Test (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Sterile Packaging Integrity (Engineering specification)	Tested; conforms to specifications. (No specific test data provided.)
Biocompatibility of materials (Implied by NF EN ISO 10993 standards)	Materials' biocompatibility assessed; no safety concern. (No specific test data provided.)
Device supplied EO-sterilized; limits additional risk of residual ethylene oxide intoxication.	Validation of aeration method (Implied successful). (No specific test details provided.)
Differences in dimensions (Length, Outer Diameter) from predicates do not impair safety or performance.	(Implied conclusion from testing, no specific comparative study data provided for new dimensions.)
Presence of a balloon and its position does not impact calibration function compared to predicate.	(Implied conclusion from testing, no specific comparative study data provided.)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the performance tests mentioned (e.g., dimensional analysis, reliability, burst volume, gluing, joint strength, packaging integrity).
The data provenance (e.g., country of origin, retrospective or prospective) for these tests is not mentioned. These appear to be bench or lab tests rather than clinical studies on human subjects. For biocompatibility, it refers to standards, but no origin of direct test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the provided document details bench testing and conformance to standards, not a clinical study requiring expert ground truth for interpretation of images or patient data.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical tool, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance criteria appears to be adherence to established international and national standards (e.g., ISO, ASTM, NF EN ISO) and internal engineering specifications for parameters like dimensions, material properties, and functional reliability. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these tests.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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

June 23, 2015

Medical Innovation Development % Mélanie Fouilland Quality/RA Manager 9, Chemin Du Jubin Dardilly, RHONE 69570 France

Re: K142548

Trade/Device Name: MIDSLEEVE™ Calibration Tube for Sleeve Gastrectomy Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 11, 2015 Received: May 14, 2015

Dear Mélanie Fouilland,

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.

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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142548

Device Name

MIDSLEEVE Calibration Tube for Sleeve Gastrectomy

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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T : +334 78 17 48 04 F : +334 72 82 91 23

510(k) SUMMARY

Prepared: Updated: Applicant information: Address:

September 3rd, 2014 June 19th, 2015 Medical Innovation Développement 9, Chemin du Jubin 69570 DARDILLY FRANCE

510(k) Number : Telephone Number: Fax Number: Name of Contact Person: K142548 +334 78 17 48 04 +334 72 82 91 23 Mélanie FOUILLAND Quality/RA Manger mid@midband.fr

21 CFR 876.5980

E-mail address

Signature

Trade Name: Common Name: Device classification: Product Code: Regulation Number:

MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy Gastrointestinal tube and accessories Class II KNT

Predicate Devices:

REALIZE™ Calibration Tube K071764 Boehringer Laboratories Gastric Sizing Tube K130483

™, Calibration Tube for Sleeve
nal tube and accessories

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1. Device Description

Image /page/4/Figure/5 description: The image shows a medical device with several labeled parts. The parts include a balloon, a distal tip, a silicone body, distal side holes for suction, and a valve for inflation. The balloon is blue and inflated, and the distal side holes are located on a loop of tubing.

1.1 Intended use

MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.

1.2 Principles of operation

The balloon is initially deflated and in contact with the silicone body (see 1. below), which enables the insertion of the tube inside the throat to reach the patient's stomach.

As air or saline solution is injected through the valve, the balloon unfolds from the silicone body, enabling the start of its inflation (2).

Image /page/4/Figure/11 description: The image contains three pictures of a blue object. The first picture is labeled with the number 1, the second picture is labeled with the number 2, and the third picture is labeled with the number 3. The third picture has a measurement of 6 cm.

When fully inflated, the balloon, specific to MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy and designed to fit the anatomy of the gastric antrum, obtains its final shape with an air or saline solution volume of 10 to 50cc (3).

This step allows for calibration of the residual gastric antrum volume: the balloon is deflated and the stomach is then stapled and dissected following the position of the tube.

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1.3 Intended performance

The targeted performance levels are the following:

MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is indicated allows an intubation A through the patient's mouth and down towards the stomach,

MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy allows simpler calibration of the A gastric pouch to be preserved during sleeve gastrectomy procedure as compared to the typical method of calibration (i.e., use of a nasogastric tube) by the surgeon.

A The dimension of the preserved gastric pouch obtained after using MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy optimizes sleeve gastrectomy effectiveness (weight loss and quality of life),

MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy allows combination with a suction A system in order to drain gastric fluids and/or to perform a leak test after the stapling step.

2. Predicate Device Comparison Summary

2.1 Table of comparison

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Medical Innovation Développement 9, Chemin du Jubin

69570 DARDILLY-France

	Proposed device	Predicate devices
Device ProprietaryName	MIDSLEEVE™, Calibration Tubefor Sleeve Gastrectomy	REALIZE™ Gastric Calibration Tube	Boehringer Laboratories Gastric SizingTube
510(k) Number	K142548	K 071764	K 130483
Device CommonName	Gastrointestinal Tube andAccessories	Gastrointestinal tubes	Gastrointestinal Tube and Accessories
Device ClassificationName	Tubes, Gastrointestinal (andAccessories)	Tubes, Gastrointestinal (andAccessories)	Tubes, Gastrointestinal (andAccessories)
Manufacturer	Medical Innovation Développement	Obtech Medical SARL	Boehringer Laboratories, LLC
Product Code	KNT	KNT	KNT
FDA RegulationNumber	21 CFR 876.5980	21 CFR 876.5980	21 CFR 876.5980
Device Classification	Class II510(k) Premarket Notification	Class II510(k) Premarket Notification	Class II510(k) Premarket Notification
Review AdvisoryCommittee	Gastroenterology/ Urology	Gastroenterology/ Urology	Gastroenterology/ Urology
		Intended Use
Indications for UseStatement	MIDSLEEVE™, Calibration Tubefor Sleeve Gastrectomy is indicatedfor use in the bariatric procedureknown as Longitudinal SleeveGastrectomy (LSG), to drain &remove gastric fluid and to providea calibration of the gastric pouch.	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 Boehringer Laboratories GastricSizing Tube is indicated for use ingastric and bariatric surgicalprocedures for the application ofsuction, stomach decompression,drainage of gastric fluids, irrigation andto serve as a sizing tube.
Typical Use	Sleeve gastrectomy procedures	Gastric and bariatric procedures	Gastric and bariatric procedures
Patient Population	Individuals undergoing LongitudinalSleeve Gastrectomy procedure	Individuals undergoing bariatric and/orgastric procedures	Individuals undergoing bariatric and/orgastric procedures
Functions	Suction, drainage, sizing, irrigation	Suction, drainage, sizing, irrigation	Suction, drainage, sizing, irrigation
Environments of Use	Surgery Centers, Hospitals	Surgery Centers, Hospitals	Surgery Centers, Hospitals
Intraoperative Use	Yes	Yes	Yes
		Design Characteristics
Outer Diameter(French)	37.5Fr	38Fr	32Fr, 36Fr, or 40Fr
Length	900 mm	745 mm	760 mm
Tubing	Single lumen with rounded, opendistal end	Single lumen with rounded, closeddistal end	Single lumen with rounded, closeddistal end
Distal side holes	Yes	Yes	Yes
Balloon and InflationValve	Yes	Yes	No
Balloon Position	Side of the distal end	6.8 cm from the distal end	NA
Markings	Every 5 cm, from 15 to 70 cm fromthe distal end of the tube	Markings are provided with the zeroreference located approximately 39.6cm from the proximal end of theballoon	Blue marking 30 – 40 – 50cm from thedistal end of the tube
		Materials
Tubing Material	Silicone	Silicone	Styrene-Ethylene-Butylene-Styrene(SEBS Co-polymer)
		Biological characteristics
Sterility	Supplied sterile, disposable, singlepatient use	Supplied non-sterile, disposable,single patient use	Supplied non-sterile, disposable,single patient use

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2.2 Discussion

2.2.1 Intended use

The indications for use statement for the proposed device contain language that is not specifically incorporated in the indications for use statements of the predicate devices. The proposed device indications for use statement include "calibration". While the exact text "calibration" is not specifically included in the indications for use statements of the predicate devices, it refers to the terms "size", "sizing", "provide visible and tactile delineation of the stomach", and "size a gastric pouch".

The indications for use statement of the proposed device contain the text "Sleeve Gastrectomy" whereas it is not specifically stated in the indications for use statements of the predicate devices. It is included in the procedures referred to as "gastric and bariatric surgical procedures" in the indications for use statements of the predicate devices. The three devices are intended to perform the same functions: suction, drainage, sizing and irrigation.

The range of surgical applications and the patient population defined for the proposed device are not as wide as the ones defined for the predicate devices. However, all surgical applications for the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy are within the range of surgical applications as defined by the predicate devices and do not affect the safety or performance of the device.

2.2.2 Technical Characteristics

Many similarities can be observed in the intended use of the three devices, including their main design characteristics and their general indications for use. However, differences concerning sterility, the tube and the balloon were identified.

Whereas the proposed device is supplied EO-sterilized, its predicate devices are supplied nonsterile. The proposed device is safer when it comes to infection risks and any additional risk of residual ethylene oxide intoxication is limited by the use of a validated aeration method (see section 14).

The tubes of the three devices differ slightly in their dimensions, materials and the features they include. As they allow the same calibration of a gastric pouch to be performed and do not make the tube handling more difficult, the differences of length and outer diameter do not impair the safety and performance of the device. Differences from the predicate devices which may exist concerning the materials used in the proposed device raise no safety concern since the biocompatibility of these materials was assessed (see section 15). Specificities concerning the features of the proposed device, such as the presence of a colored orientation band, the format and spatial distribution of the markings and the absence of suction connector do not impair its safety and performance and only improve the ease of use as compared to the predicate device.

The presence of a balloon on the proposed device allows calibration to be achieved. Its specific position on the tube does not impact this function as compared to the REALIZE™ Gastric Calibration Tube. No additional risk is implied and the main principles of operation of the device are not impacted.

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The differences discussed above do not affect the safety and effectiveness of the new device when used as labeled.

2.2.3 Performance testing

The MIDSLEEVE™, Calibration tube for Sleeve gastrectomy conforms to:

ISO 11607-01:2009, Packaging for terminally sterilized medical devices - Part 1: . Requirements for materials, sterile barrier systems and packaging systems

ISO 11607-01:2009, Packaging for terminally sterilized medical devices – Part 2: Validation . requirements for forming, sealing and assembly processes

. ASTM F88-09:2009, Standard test Method for Seal Strength of Flexible Barrier Materials

ASTM F1980-07:2011, Standard Guide for Accelerated Aging of Sterile Barrier Systems for . Medical Devices

NF EN ISO 10993-1:2010 : Biological evaluation of medical devices - Part 1: Evaluation . and testing within a risk management process

ASTM F1140/F1140M-13: Standard Test Methods for Internal Pressurization Failure . Resistance of Unrestrained Packages

NF EN ISO 10993-5:2010: Biological evaluation of medical devices -- Part 5: Tests for In ● Vitro cytotoxicity

NF EN ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for . irritation and skin sensitization

The MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy conforms engineering specifications for usability and reliability:

0 Dimensional Analysis
0 Reliability and Safety of the Distal Balloon Inflation and Proximal Valve
Burst Volume Testing on the Inflated Balloon 0
0 Distal End piece Gluing Reliability
o Valve to Tube Joint Strength Test
. Sterile Packaging Integrity

The performance testing conducted with the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy referenced above indicates the new device performs equivalently to, or better than the predicate devices.

3. Conclusion

As evidenced from the similarities and the differences discussed above and from the intended use, technological characteristics and performance testing conducted, the MIDSLEEVE™, Calibration Tube for Sleeve Gastrectomy is as safe, as effective and performs as well as the predicate devices.

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.