(94 days)
Not Found
No
The summary describes a simple mechanical splinting tube used to assist in inserting a videoscope. There is no mention of any software, image processing, or AI/ML terms.
No
The device is described as a "splinting tube" used for "assisting procedure of inserting a videoscope into the biliary tract." It facilitates a procedure but does not directly treat a disease or condition itself.
No
The device is described as a "single use splinting tube... used for assisting procedure of inserting a videoscope into the biliary tract." Its function is mechanical assistance for scope insertion, not diagnosis.
No
The device description explicitly states it is a "single use splinting tube," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for assisting in the insertion of a videoscope into the biliary tract for endoscopy and endoscopic surgery. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The device is a splinting tube used to facilitate the insertion of another medical device (a videoscope). This is a physical tool used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided description does not mention any such use or interaction with biological specimens outside the body.
Therefore, this device falls under the category of a medical device used for a surgical or endoscopic procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract
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.
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
§ 876.5980 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.
0
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:
.
I
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
II
Gastroenterology/Urology
KNT
Image /page/0/Picture/24 description: The image shows a free-hand sketch of an abstract shape. The shape appears to be a polygon with several sides, and there are some lines inside the shape that may represent internal features or details. The sketch is done in black ink on a white background, and the lines are somewhat jagged and uneven, giving it a rough, unfinished appearance.
1
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
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.
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.
2
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 Device
ST-Y0002-S, ST-Y0002-H
ST-Y0003-S, ST-Y0003-H | Predicate Device
ST-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-H
Length: 12 x 6 mm,
Shape: Oval
Place: Provided on two places
ST-Y0003-S, ST-Y0003-H
None | None |
| Air flow lumen
cross-section shape | Oval (1.4mm x 1.1 mm) | Rectangle (1.4 mm x 1.0 mm) |
| Distal tip shape | Rounded shape made of
silicone rubber adhesive | Silicone rubber distal tip
bonded with silicone
rubber adhesive |
| Sterilization before
shipment | Non sterile | Sterile |
| Balloon inflation device | Syringe | Balloon Control Unit
(OBCU) |
3/4
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:
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3
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
. . .
: 上
.
、
4/4
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·
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:
4
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
5
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
6
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
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