(15 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the mechanical and optical aspects of the endoscope system.
No.
The device is a videoscope for examination of the digestive tract, not a therapeutic intervention.
Yes
Explanation: The device is a videoscope system used for examining the upper and lower digestive tract, indicating its use in diagnosing conditions within those anatomical sites. The "Intended Use" section explicitly states its use within the digestive tract, implying a diagnostic function.
No
The device description explicitly states it is a "small intestinal videoscope" and mentions hardware components like balloons, a splinting tube, and other ancillary equipment, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for endoscopic examination and surgery within the digestive tract. This involves direct visualization and intervention within the body, not the analysis of samples taken from the body.
- Device Description: The description focuses on the physical components of the endoscope system and its mechanism for navigating the small intestine. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material in vitro (outside the body) to diagnose a condition.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a tool for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
Product codes (comma separated list FDA assigned to the subject device)
78 FDA, KNT
Device Description
The subject device, Small I surgery within the small intrisune.
The subject device utilizes senuential geolovment of two bailouns, one attached to an gastrointestinal . ment of the endoscope
well within the small intestine. The suppor over can access inrough the small intestine via either oral or anal introduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and 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.
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.
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JUN 2 8 2005
2005.6.8
SMDA 510(k) SUMMARY SMALL INTESTINAL VIDEOSCOPE SYSTEM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with This summary of 5 ro(K) Safety and 21CFR, Part 807, Subpart E, Section 807.92.
1. GENERAL INFORMATION
| Applicant | Aizu Olympus Co., Ltd
500 Aza Muranishi Ooaza
Niidera, Monden-machi
Aizuwakamatsu-shi, Fukushima, JAPAN 965-8520
Establishment Registration No.: 9610595 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent | Akiko Fukagawa
Olympus Medical Systems Corp.
2951 Ishikawa-cho,
Hachioji-shi, Tokyo, 192-8507, Japan
Phone: +81-426-2891
Fax: +81-426-3174
E-mail: akiko_fukagawa@ot.olympus.co.jp
Establishment Registration No.: 8010047 |
| Official Correspondent | Laura Storms-Tyler
Director, Regulatory Affairs and Quality Assurance
Olympus America Inc.
Two Corporate Center Drive, Melville,
NY 11747-9058
Phone: 631-844-5688
Fax: 631-844-5554
Establishment Registration No.: 2429304 |
2. Device Identification
| Trade Name: | SMALL INTESTINAL VIDEOSCOPE SYSTEM |
|---|---|
| Common Name: | Small Intestinal Videoscope |
| Regulation Number: | 21CFR 876.1500/876.5980 |
| Regulation Name: | Endoscope and accessories/Gastrointestinal tube and accessories |
| Class: | II |
| Product Code: | 78 FDA/KNT |
1
3. Predicate Device
The following listed devices are considered as predicate devices in consideration of their characteristics, and the following table shows their regulatory histories.
| Model | 510(k) # | Manufacturer | Class | Product Code |
|---|---|---|---|---|
| PCF-160AL/I | K001241 | Olympus Optical Co., LTD | II | 78 FDF |
| XSIF-1TQ140A | ||||
| Small Intestinal Videoscope | K031256 | Olympus Opt-electronics Co., | ||
| LTD | II | 78 FDA / KOG | ||
| Fujinon Double Balloon | ||||
| Enteroscopy System | K040048 | Fujinon, Inc. | II | 78 FDA / KNT |
4. Device Description
The subject device, Small I surgery within the small intrisune.
The subject device utilizes senuential geolovment of two bailouns, one attached to an gastrointestinal . ment of the endoscope
well within the small intestine. The suppor over can access inrough the small intestine via either oral or anal introduction.
5. Intended Use of the device
SMALL INTESTW !
This system is a makes of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
6. Comparison of Technological Characteristics
Below is the comparison table between the subject devices and predicate device.
COMPARISON OF SPECIFICATIONS (With K001241 and K031256) MODEL: XSIF-160DB(Subject Device) vs. XSIF-1TQ140A and PCF-160ALI(Predicate Devices)
| Specifications | XSIF-160DB
(Subject Device) | XSIF-1TQ140A
(Predicate Device) | PCF-160AL/I
(Predicate Device) |
|-----------------------------------------|--------------------------------|------------------------------------|-----------------------------------|
| Field of View | 140° | 140° | 140° |
| Depth of Field | 3100 mm | 3100 mm | 3~100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of
Distal End | φ 9.2 mm | φ 10.9 mm | φ 11.3 mm |
| Outer Diameter of
Insertion Tube | φ 9.2 mm | φ 11.3 mm | φ 11.5 mm |
| Working Length | 2000 mm | 2350mm | 1680mm (L)
1330mm (I) |
| Inner Diameter of
Instrument Channel | φ 2.8 mm | φ 3.7mm | φ 3.2 mm |
2
COMPARISON OF SPECIFICATIONS(With K040048) MODEL: XSIF-160DB(Subject Device) vs. EN-450P5/20(Predicate Device)
| Specifications | XSIF-160DB
(Subject Device) | EN-450P5/20
(Predicate Device) |
|--------------------------------------|--------------------------------|-----------------------------------|
| Field of View | 140° | 120° |
| Depth of Field | 3100 mm | 5100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of Distal End | φ 9.2 mm | φ 8.5 mm |
| Outer Diameter of Insertion Tube | φ 9.2 mm | φ 8.5 mm |
| Inner Diameter of Instrument Channel | φ 2.8 mm | φ 2.2 mm |
MODEL: XST-BY(Subject Device) vs. TS-12140(Predicate Device)
| Specifications | XST-BY
(Subject Device) | TS-12140
(Predicate Device) |
|----------------|----------------------------|--------------------------------|
| Outer Diameter | φ 14.8 mm | φ 12.2 mm |
| Inner Diameter | φ 11mm | φ 10 mm |
| Working Length | 1320 mm | 1350 mm |
| Total Length | 1400 mm | 1450 mm |
MODEL: MAJ-1440(Subject Device) vs. PB-10(Predicate Device)
| Specifications | MAJ-1440
(Subject Device) | PB-10
(Predicate Device) |
|-------------------------|------------------------------|-----------------------------|
| Set Pressure of Balloon | 5.4 kpa + - 2.6 kpa | 5.6 kpa + - 2 kpa |
| Power Supply | 120V/230V | 120V/230V |
| Dimensions | 370(W)×242(H)×473.5(D) | 300(W)×200(H)×300(D) |
| Weight | 19.5 kg | 8.7 kg |
7. Materials
All the patient contact materials used in the SMALL INTESTINAL VIDEOSCOPE SYSTEM are identical to those used in the legally marketed Olympus devices.
8. Summary including conclusion drawn from non-clinical tests
When compared to the predicate devices, SMALL INTESTINAL VIDEOSCOPE SYSTEM do not the safety and offectiveness, In intended use, method of operation, material, or design that could affect the safety and effectiveness. In addition, the provided of operation, or design that could and efficacy of the subject system.
3
Image /page/3/Picture/2 description: The image shows a black and white drawing of a bird in flight. The bird is facing to the right, and its wings are spread out. The bird's body is thin and streamlined, and its tail is long and pointed. There is some text in a circular pattern to the left of the bird. The drawing is simple and elegant.
JUN 2 8 2005
, ત
Food and Drug Administration 9200 Corporate Boulevard Rockville -MD 20850
Olympus Medical Systems Corporation c/o Neil E. Devine. Jr. Intertek Testing Services NA. Inc. 3033 Madison Avenue, SE GRAND RAPIDS MI 49548
Re: K051551
Trade/Device Name: Small Intestine Videoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: FDA Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Product Code: KNT Regulatory Class: II Dated: June 10, 2005 Received: June 13, 2005
Dear Mr. Devine:
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 (Premarket Approval), it may be subject to such 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 nanufacturing 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prodicated 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
Indications for Use
A051551 510(k) Number(if known):
Device Name: SMALL INTESTINAL VIDEOSCOPE SYSTEM
Indications for Use:
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
Daniel G. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)