The single use splinting tube, model ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, and ST-Y0003-H used for assisting procedure of inserting a videoscope into the biliary tract , using with a VIDEOSCOPE XCHF-T160.

AI/ML Overview

The provided 510(k) summary (K091759) for the "Single Use Splinting Tube" does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. The information focuses on device description, intended use, and a comparison of technological characteristics to establish that the new device does not introduce new questions of safety or effectiveness. It is not a clinical performance study report.

Here's a breakdown of why the requested information is not available in the provided text:

Device Type: The device is a 'Single Use Splinting Tube', which is a manual medical instrument, not a diagnostic AI system or a device that requires performance metrics like sensitivity or specificity.
510(k) Process: For this type of device and submission, the FDA's 510(k) pathway primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing design, materials, intended use, and functional characteristics to ensure the new device is as safe and effective as the predicate. It does not typically involve extensive clinical trials or performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Therefore, the following points cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance:
* Not applicable as this is not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy. The "performance" in this context refers to its functional equivalence to the predicate.

2. Sample size used for the test set and the data provenance:
* No test set for performance evaluation (e.g., diagnostic accuracy) is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
* Not applicable. Ground truth establishment for diagnostic performance is not relevant for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable.

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. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable.

8. The sample size for the training set:
* Not applicable. There is no mention of a training set as this is not an algorithm or AI device.

9. How the ground truth for the training set was established:
* Not applicable.

Summary of available information relevant to acceptance and study:

The provided document describes a comparison study against a predicate device (K071254, Single Use Splinting Tube ST-SB-1). The "acceptance criteria" can be inferred as demonstrating substantial equivalence by proving that the subject device (ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H) is similar enough to the predicate device in intended use, specifications, materials, and design, such that it does not raise new questions of safety or effectiveness.

Table 1: Comparison of Specifications (Functionally equivalent as the "demonstration of performance")

Specifications	Subject DeviceST-Y0002-S, ST-Y0002-HST-Y0003-S, ST-Y0003-H	Predicate DeviceST-SB1	Difference & Implication (Interpretation of "Performance" in this context)
Balloon Outer Diameter	$\phi$ 25 mm	$\phi$ 40mm	Smaller. Implication: The subject device has a smaller balloon. The submission implies this change does not affect safety or effectiveness for its intended use with the VIDEOSCOPE XCHF-T160 within the biliary tract.
Length of Balloon	20mm	52mm	Shorter. Implication: The subject device has a shorter balloon length. The submission implies this change does not affect safety or effectiveness for its intended use.
Tube Outer Diameter	$\phi$ 10 mm	$\phi$ 13.2mm	Smaller. Implication: The subject device has a smaller tube outer diameter. This is a design change that the applicant asserts does not negatively impact safety or effectiveness.
Tube Inner Diameter	$\phi$ 7 mm	$\phi$ 11mm	Smaller. Implication: Smaller inner diameter. The applicant attests this is acceptable for the device's function.
Total Length	1200mm	1400mm	Shorter. Implication: The subject device is shorter overall. This change likely requires operators to be aware of the length difference when using the device.
Working Length	1120mm	1320mm	Shorter. Implication: Shorter working length, similar to the total length.
Side Holes	ST-Y0002-S, ST-Y0002-H: Length: 12 x 6 mm, Shape: Oval, Place: Provided on two placesST-Y0003-S, ST-Y0003-H: None	None	Presence of Side Holes in some models. Implication: This is a key difference. The applicant must have demonstrated that the addition of side holes in some models (ST-Y0002-S, ST-Y0002-H) does not compromise the device's safety or effectiveness compared to the predicate without side holes or the other subject models without side holes. This would likely have been addressed through bench testing to ensure structural integrity and functional performance (e.g., maintaining inflation pressure, proper fluid/air flow characteristics) or clinical rationale that the side holes aid in the intended purpose without adverse effects. The 510(k) summary does not detail these tests.
Air flow lumen cross-section shape	Oval (1.4mm x 1.1 mm)	Rectangle (1.4 mm x 1.0 mm)	Different shape. Implication: A change in the shape of the air flow lumen. The applicant would need to ensure that this change does not negatively impact the ability to inflate/deflate the balloon or any other function dependent on this lumen.
Distal tip shape	Rounded shape made of silicone rubber adhesive	Silicone rubber distal tip bonded with silicone rubber adhesive	Minor difference in description. Implication: The wording suggests a functionally similar distal tip, designed to be atraumatic.
Sterilization before shipment	Non sterile	Sterile	Non-sterile vs. Sterile. Implication: This is a significant difference. The subject device is shipped non-sterile, meaning it must be sterilized by the user before use. The predicate was shipped sterile. The applicant must have justified that the non-sterile shipment of the subject device is acceptable, presuming there are clear instructions for terminal sterilization by the end-user before clinical use. This is a crucial procedural difference, not a performance metric.
Balloon inflation device	Syringe	Balloon Control Unit (OBCU)	Syringe vs. Dedicated Control Unit. Implication: The subject device uses a simpler syringe for balloon inflation, whereas the predicate used a dedicated Balloon Control Unit. The applicant would need to ensure that inflation with a syringe is safe, effective, and controllable to achieve the desired balloon pressure/volume without risk of over-inflation or inadequate inflation for the device's intended function. This change simplifies the accessory required for operation.

**Conclusion from the 510(k) **

"Whien compared to the predicate device, the Single Use Splinting Tube, model ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, and ST-Y0003-H do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."

This statement is the "study" result in the context of a 510(k) for this type of device; the comparison table and the rationale provided were deemed sufficient by the FDA to demonstrate substantial equivalence, thus "meeting acceptance criteria" for market clearance. The acceptance criteria are "substantial equivalence" as defined by the FDA's regulatory framework. The study is the comparison of technological characteristics.

Summary

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KO91759

SEP 1 8 2009

510(k) SUMMARY

Single Use Splinting Tube ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H

General Information 1

Official Correspondent:

Applicant:
.

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047

Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olvmous America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com

OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, Japan 190-0182 Establishment Registration No: 003637092

2 Device Identification

트 Device Trade Name:
Manufacturer:
I Common Name:
동 Regulation Number:

Regulation Name: ■

Regulatory Class:
월 Classification Panel:
Product Code:

SINGLE USE SPLINTING TUBE ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H

SINGLE USE SPLINTING TUBE

21 CFR 876.5980

Gastrointestinal tube and accessories

Gastroenterology/Urology

KNT

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Predicate Device Information 3

Device Name:	Single Use Splinting Tube ST-SB-1
Common Name:	Single Use Splinting Tube
Manufacturer:	OLYMPUS MEDICAL SYSTEMS CORP.
510(k) No.	K071254

4 Device Description

5 Indications for Use

This instrument has been designed to be used with a VIDEOSCOPE XCHF-T160. Use this instrument for endoscopy and endoscopic surgery within the biliary tract.

Comparison of Technological Characteristics б

The Single Use Splinting Tube, model ST-Y0002-S, ST-Y0003-S, and ST-Y0003-H are basically identical to the predicate device in intended use, and similar in specifications except for the addition of side holes. Companson between the subject and predicate devices is shown in Table 1.

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Table 1. Comparison of Specifications Subject Device: Single Use Splinting Tube · ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H

. .

Predicate Device: Single Use Splinting Tube ST-SB1 (K071254)

Specifications	Subject DeviceST-Y0002-S, ST-Y0002-HST-Y0003-S, ST-Y0003-H	Predicate DeviceST-SB1
Balloon Outer Diameter	$\phi$ 25 mm	$\phi$ 40mm
Length of Balloon	20mm	52mm
Tube Outer Diameter	$\phi$ 10 mm	$\phi$ 13.2mm
Tube Inner Diameter	$\phi$ 7 mm	$\phi$ 11mm
Total Length	1200mm	1400mm
Working Length	1120mm	1320mm
Side Holes	ST-Y0002-S, ST-Y0002-HLength: 12 x 6 mm,Shape: OvalPlace: Provided on two placesST-Y0003-S, ST-Y0003-HNone	None
Air flow lumencross-section shape	Oval (1.4mm x 1.1 mm)	Rectangle (1.4 mm x 1.0 mm)
Distal tip shape	Rounded shape made ofsilicone rubber adhesive	Silicone rubber distal tipbonded with siliconerubber adhesive
Sterilization beforeshipment	Non sterile	Sterile
Balloon inflation device	Syringe	Balloon Control Unit(OBCU)

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7 Conclusion

. :

Whien compared to the predicate device, the Single Use Splinting Tube, model ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, and ST-Y0003-H do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device. Sporation,

、

Carlos Concession

. . .

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP | 8 2009

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

OLYMPUS MEDICAL SYSTEMS CORP. % Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K091759

Trade/Device Name: Single Use Splinting Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 12, 2009 Received: June 22, 2009

Dear Ms. Kluesner:

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); medical device reporting (reporting of medical

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Page 2 -

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: SINGLE USE SPLINTING TUBE

ST-Y0002-S, ST-Y0002-H, ST-Y0003-S, ST-Y0003-H

1091259

Indications For Use:

This instrument has been designed to be used with the VIDEOSCOPE XCHF-T160 for endoscopy and endoscopic surgery within the biliary tract.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

124

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device 510(k) Number

Page 1 of

: Øcego

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.