(87 days)
K954451, K# Unknown, K# Unknown
Not Found
No
The device description focuses on the physical characteristics and mechanical function of a silicone tube used as a splint during colonoscopy. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is intended to prevent the reformation of the sigmoid loop in a colon during a medical procedure, which directly pertains to the treatment and management of a patient's physiological condition.
No
The device's intended use is to prevent the reformation of the sigmoid loop and facilitate the advancement of a colonoscope, which are therapeutic and assistive functions during a colonoscopy, not diagnostic ones.
No
The device description clearly outlines a physical, disposable silicone tube with a soft distal tip, proximal grip, and injection port, indicating it is a hardware device, not software.
Based on the provided information, the InHealth Soft Sleeve Colonoscope Splint is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this device is used within the body during a colonoscopy procedure to assist with the advancement of a colonoscope. It does not analyze or test any biological samples.
- The device's function is mechanical. It acts as a splint or overtube to prevent looping of the colonoscope and facilitate its movement. This is a physical function, not a diagnostic one.
Therefore, the InHealth Soft Sleeve Colonoscope Splint is a medical device, but it falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for 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 Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.
Product codes (comma separated list FDA assigned to the subject device)
FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sigmoid colon, colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954451, K# Unknown, K# Unknown
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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
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
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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.
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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:
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.
(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 Use
| Per 21 CFR 801.109 | OR | Over-the-Counter |
|---|---|---|
| ---------------------------------------- | ---- | ------------------ |