The InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.

Device Description

The InHealth Soft Sleeve Colonoscope Splint is a disposable splint or overtube for use in colonoscopy to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. This device is a silicone tube with a soft distal tip and a proximal grip. The distal tip provides a soft, conforming and flexible tapered shape that hugs the scope and facilitates insertion. The entire splint, with the exception of the outer surface of the proximal grip, is coated with a lubricious, hydrophilic coating. This lubricious coating, when wetted, enables a smooth passage of the device along the colonoscope and of the splint through the sigmoid colon. The proximal grip is fitted with an injection port for injecting water into the inside of the splint tube to facilitate lubrication. The tip is grooved to allow flow of water from the inside diameter of the splint to the outside diameter to provide a controlled lubrication of the splint, the colonoscope, and the surrounding mucosa. The proximal grip, which is larger than the shaft, ensures that the entire tube does not pass through the anus and enter the rectum. The Soft Sleeve Splint is a non-sterile disposable device, intended for one-time use only, not intended for reuse.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "InHealth Soft Sleeve Colonoscope Splint." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through extensive clinical studies as might be required for a PMA. Therefore, the document does not contain information about acceptance criteria, detailed study designs, sample sizes for test/training sets, or expert ground truthing as typically requested for AI/ML device evaluations.

The closest analogue to "acceptance criteria" and "reported device performance" in this context is the concept of "substantial equivalence" to predicate devices, focusing on technological characteristics and intended use.

Here's the information parsed from the document based on your request, with an emphasis on what is not available within this type of regulatory submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (as described for Substantial Equivalence)
Intended Use: Prevent reformation of sigmoid loop, enable easy scope advancement, avoid colon damage during colonoscopy.	Matches Intended Use: Indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. Intended to provide for easy advancement of the scope while avoiding damage to the colon.
Material/Design Suitability: Coated shaft for colonoscope advancement, appropriate for non-sterile intact body orifice.	Equivalent Materials/Design: Silicone tube with soft distal tip and proximal grip. Hydrophilic coating. Proximal grip with injection port for lubrication. Designed for colonoscope to pass through. Minimizes gap between scope and splint.
Safety: Non-sterile (as predicate), one-time use (improves over predicate needing cleaning/disinfection).	Equivalent Safety Profile: Provided non-sterile (like Olympus predicate), intended for use in non-sterile intact body orifice. Disposable, one-time use (addressing cleaning requirements of predicate).
Technological Equivalence: No new technology or change in intended use compared to predicates.	Minor Differences noted for improvement: Soft elastic distal tip (vs. rigid shaft of predicate). Water-activated lubricious hydrophilic surface (vs. lubricant application for Olympus predicate). Minimizes gap between colonoscope and splint (vs. gap remaining with predicates).

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

Not Applicable / Not Provided: This 510(k) submission does not describe a performance study with a test set that would have a sample size or data provenance as typically understood for AI/ML device evaluations. The submission relies on demonstrating substantial equivalence to existing devices.

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

Not Applicable / Not Provided: No studies involving "ground truth" establishment by experts are described in this 510(k) submission.

4. Adjudication method for the test set

Not Applicable / Not Provided: No test set or adjudication method is described.

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

Not Applicable / Not Provided: This device is a physical medical instrument (a colonoscope splint), not an AI/ML software device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Not Applicable / Not Provided: As this is a physical medical device, not an algorithm, this question is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not Provided: No ground truth data is described as being used for this 510(k) submission.

8. The sample size for the training set

Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable / Not Provided: As this device is not an AI/ML algorithm, this question is not relevant.

Summary

{0}------------------------------------------------

K023259
Pageing3

Helix Medical, Inc. 510(k) Summary InHealth Soft Sleeve Colonoscope Splint

DEC 2 6 2002

1. NAME OF SUBMITTER

InHealth Technologies, a business unit of Helix Medical. Inc. 1110 Mark Ave. 93013 Carpinteria, Ca

Establishment Registration Number: 2025182

DEVICE NAME AND CLASSIFICATION ll.

Proprietary Name: InHealth Soft Sleeve Colonoscope Splint Common or Usual Name: Colonoscope Splint

Class II: 21 CFR 876.1500

The Soft Sleeve Colonoscope Splint is classified as 'Endoscope and Accessories'. The classification reads "An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eve and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices." The product code for this device is FDF, Colonoscope, Gastro-Urology.

III. PREDICATE DEVICES

Olympus Splinting Tube, Olympus America, Inc., Melville, NY; K954451 .
Pentax Splinting Tube, Pentax Precision Inst., Orangeburg, NY; K# Unknown .
ACMI Splinting Tube, AMCI Corporation, Houston, TX; K# Unknown ●

DESCRIPTION IV.

{1}------------------------------------------------

*023259
Proj c 24f 3

the outer surface of the proximal grip, is coated with a lubricious, hydrophilic coating. This lubricious coating, when wetted, enables a smooth passage of the device along the colonoscope and of the splint through the sigmoid colon. The proximal grip is fitted with an injection port for injecting water into the inside of the splint tube to facilitate lubrication. The tip is grooved to allow flow of water from the inside diameter of the splint to the outside diameter to provide a controlled lubrication of the splint, the colonoscope, and the surrounding mucosa. The proximal grip, which is larger than the shaft, ensures that the entire tube does not pass through the anus and enter the rectum. The Soft Sleeve Splint is a non-sterile disposable device, intended for one-time use only, not intended for reuse.

V. INTENDED USE

The InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.

TECHNOLOGICAL CHARACTERISTICS VI.

The Soft Sleeve Splint is intended for the same use as its predicate devices, Olympus Splinting Tube. Pentax Splinting Tube, and the ACMI Splinting Tube. All these devices are indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure.

The Olympus Splinting Tube is offered as a non-sterile product and is cleaned and disinfected between uses. As with the predicate devices, the InHealth Soft Sleeve Splint is intended for use in a non-sterile intact body orifice, and therefore is also provided non-sterile. The InHealth Soft Sleeve Splint is however, provided as a disposable device and therefore does not require any special cleaning. There is no reuse of this device.

The design, form, and materials of the Soft Sleeve Splint and its predicate devices are equivalent, in that all are designed to be a coated shaft through which the colonoscope is advanced during a colonoscopy. Helix Medical has introduced no new technology, or change in the intended use with the Soft Sleeve Splint. The Soft Sleeve Splint differs slightly in that it has a soft elastic distal tip rather than a rigid shaft.

The three predicate devices have a rubber or plastic type coating to provide a smooth splint surface. The Olympus requires an application of a lubricant to the splint prior to use. The InHealth Soft Sleeve Colonoscope Splint has a water

{2}------------------------------------------------

K02 3259
Page 3 of 3

activated lubricious hydrophilic surface that provides a smooth splint surface as well as enabling easier passage of the colonoscope through the device and the device through the colon. The proximal grip is fitted with an injection port for injecting water into the inside of the splint tube to facilitate lubrication.

All four devices are designed for the colonoscope to pass through the splint. The three predicate devices are designed such that a gap remains between the colonoscope and the splint. The InHealth Soft Sleeve Colonoscope Splint is designed to provide a soft conforming shape that hugs the scope, thus minimizing the gap.

Helix Medical considers the use of the Soft Sleeve Splint to be substantially equivalent to its predicate devices, the Olympus Splint, Pentax Splint, and the ACMI Splint.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an image of an eagle with three lines extending from its head.

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Cynthia M. Anderson Vice President of Regulatory Affairs and Quality Assurance Helix Medical, Inc. InHealth Technologies 1110 Mark Avenue CARPINTERIA CA 93013

Re: K023259

Trade/Device Name: InHealth Soft Sleeve Colonoscope Splint (Model CS1200) Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDF Dated: September 30, 2002 Received: September 30, 2002

Dear Ms. Anderson:

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 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. 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.

{4}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C Brogdon

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

Enclosure

{5}------------------------------------------------

K02-325.9

INDICATIONS FOR USE

Helix Medical, Inc. Applicant:

510(k) Number (if known): N/A*

Device Name: InHealth Soft Sleeve Colonoscope Splint

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)	Nancy C. Brogdon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K023259

Prescription UsePer 21 CFR 801.109	OR	Over-the-Counter
----------------------------------------	----	------------------

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.