(15 days)
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.
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.
The provided 510(k) summary (K051551) for the "SMALL INTESTINAL VIDEOSCOPE SYSTEM" does not include a detailed study with acceptance criteria and reported device performance in the way a modern AI/ML device submission would. This document is from 2005, and the device in question is a medical endoscope system, not an AI-powered diagnostic tool. Therefore, the traditional acceptance criteria and study design elements typically associated with AI/ML device evaluations (like sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies, etc.) are not present in this submission.
Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, and materials.
Here's an attempt to answer the questions based on the available information, noting where no direct information is provided due to the nature of the device and submission type:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" or "reported device performance" in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy) are presented in this 510(k) summary. The acceptance criteria for this type of device and submission are implicitly met by demonstrating substantial equivalence to predicate devices, meaning the device performs as safely and effectively as a legally marketed predicate device. The performance is summarized by comparing physical specifications and material commonalities.
| Area of Comparison | Acceptance Criteria (Implicit) | Reported Device Performance (as presented) |
|---|---|---|
| Technological Characteristics | No significant differences that would raise new questions of safety or effectiveness compared to predicates. | XSIF-160DB vs. K001241 (PCF-160AL/I) & K031256 (XSIF-1TQ140A):- Field of View: 140° (same as predicates)- Depth of Field: 3 |
| Intended Use | Identical or highly similar to predicate devices. | "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." (Essentially identical to general endoscope intended uses). |
| Materials | Patient contact materials are identical to those in legally marketed predicate Olympus devices. | "All the patient contact materials used in the SMALL INTESTINAL VIDEOSCOPE SYSTEM are identical to those used in the legally marketed Olympus devices." |
| Safety and Effectiveness | No new questions of safety or effectiveness are raised compared to predicate devices. Non-clinical tests support this. | "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." (This statement is slightly garbled in the scan but suggests no new safety/effectiveness concerns). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical medical device (endoscope), not a software/AI device that requires a test set of data for performance evaluation. The "study" here is a comparison of specifications and intended use against existing predicate devices.
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. No ground truth establishment by experts for a test set is part of this type of submission for a physical endoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is relevant for this device.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth concept in the context of this 510(k) submission as it's not evaluating diagnostic or interpretation performance.
8. The sample size for the training set
Not applicable. This is not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth.
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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., Ltd500 Aza Muranishi OoazaNiidera, Monden-machiAizuwakamatsu-shi, Fukushima, JAPAN 965-8520Establishment Registration No.: 9610595 |
|---|---|
| Submission Correspondent | Akiko FukagawaOlympus Medical Systems Corp.2951 Ishikawa-cho,Hachioji-shi, Tokyo, 192-8507, JapanPhone: +81-426-2891Fax: +81-426-3174E-mail: akiko_fukagawa@ot.olympus.co.jpEstablishment Registration No.: 8010047 |
| Official Correspondent | Laura Storms-TylerDirector, Regulatory Affairs and Quality AssuranceOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-9058Phone: 631-844-5688Fax: 631-844-5554Establishment 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 |
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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-1TQ140ASmall Intestinal Videoscope | K031256 | Olympus Opt-electronics Co.,LTD | II | 78 FDA / KOG |
| Fujinon Double BalloonEnteroscopy 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 | 3~100 mm | 3~100 mm | 3~100 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter ofDistal End | φ 9.2 mm | φ 10.9 mm | φ 11.3 mm |
| Outer Diameter ofInsertion Tube | φ 9.2 mm | φ 11.3 mm | φ 11.5 mm |
| Working Length | 2000 mm | 2350mm | 1680mm (L)1330mm (I) |
| Inner Diameter ofInstrument Channel | φ 2.8 mm | φ 3.7mm | φ 3.2 mm |
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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 | 3~100 mm | 5~100 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.
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JUN 2 8 2005
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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.
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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
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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)
§ 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.