(243 days)
No
The summary describes a device that mechanically regulates CO2 gas and water flow for cleaning an endoscope lens. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
No
The device is described as an instrument for CO2 gas and water feeding to clean the distal lens of a videoscope during endoscopic surgery. Its function is to clean the surgical viewing equipment, not to directly treat a patient's medical condition.
No
Explanation: The device is described as a CO2 Regulation Unit designed to feed CO2 gas and water for cleaning the distal lens of a videoscope during endoscopic surgery. Its purpose is to facilitate cleaning, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "UCR Endoscopic CO2 Regulation Unit" which feeds gas and water, indicating it is a physical hardware 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 is to feed CO₂ gas and water to clean the distal lens of an endoscope during endoscopic surgery. This is a function performed in vivo (within the body) to facilitate the surgical procedure, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The device's function is to supply gas and water for cleaning the endoscope lens, which is a procedural aid during surgery. It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Indicators: The description does not mention any activities typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
- Using reagents or calibrators
The device is an accessory used to maintain the functionality of an endoscope during a surgical procedure.
N/A
Intended Use / Indications for Use
The Endoscopic CO2 Regulation Unit UCR is indicated for use as an accessory to the Olympus XLTF-VAW Laparo-thoraco Videoscope and other ancillary equipment for CO2 gas and water feeding to clean the distal lens during endoscopic surgery.
Product codes
GCJ, HET
Device Description
The subject UCR Endoscopic CO2 Regulation Unit feeds either CO2 gas and water to clean the distal end of the XLTF-VAW Laparo-Thoraco Videoscope. The UCR unit is similar to the predicate Olympus device, the MAJ-1203 Air/Water Supply Pump unit, with the following being the major differences:
- The UCR is designed for CO2 gas and water feeding to clean the distal end of . the XLTF-VAW, whereas the predicate device MAJ-1203 was designed for air and water feeding for the XLTF-VAW.
- The UCR utilizes a decompression valve mechanism for gas dispensing, . whereas the design for the predicate device MAJ-1203 employs a diaphragm pump.
The Laparo-Thoraco Videoscope XLTF-VAW is designed to be used with a VISERA video system center OTV-S7V, light source, documentation equipment, video monitor, endo-therapy accessories, electrosurgical unit and other anciliary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. Olympus has clearance of this system under K053382
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
DEC 2 3 200>
.
510(k) SUMMARY
ENDOSCOPIC CO₂ REGULATION UNIT UCR
1 General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Establishment Registration No: 8010047 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Laura Storms-Tyler
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610
Phone: 484-896-5688
FAX: 484-896-7128
Email:Laura.storms-tyler@olympus.com
Establishment Registration No: 2429304 |
| Manufacturer: | Shirakawa Olympus Co., Ltd.
3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,
Nishishirakawa-gun, Fukushima, JAPAN 961-8061
Establishment Registration Number: 3002808148 |
2 Device Identification
| Device Trade Name: | UCR ENDOSCOPIC CO₂ REGULATION UNIT | |
|---|---|---|
| Common Name: | ENDOSCOPIC CO₂ REGULATION UNIT | |
| Regulation Number: | 21 CFR 876.1500/884.1720 | |
| Regulation Name: | Endoscope and accessories | |
| Gynecologic laparoscope and accessories | ||
| Regulatory Class: | II | |
| Classification Panel: | Laparoscope, gynecologic (and accessories) | |
| Product Code: | GCJ/HET |
1
Predicate Device Information 3
- (1) Device Name: Common Name: 510(k) No. Manufacturer:
MAJ-1203 Air/Water Supply Pump Unit Air/Water Supply Pump Unit Part of submission of K053382 Olympus Optical Co., Ltd.
Device Description ব
The subject UCR Endoscopic CO2 Regulation Unit feeds either CO2 gas and water to clean the distal end of the XLTF-VAW Laparo-Thoraco Videoscope. The UCR unit is similar to the predicate Olympus device, the MAJ-1203 Air/Water Supply Pump unit, with the following being the major differences:
- The UCR is designed for CO2 gas and water feeding to clean the distal end of . the XLTF-VAW, whereas the predicate device MAJ-1203 was designed for air and water feeding for the XLTF-VAW.
- The UCR utilizes a decompression valve mechanism for gas dispensing, . whereas the design for the predicate device MAJ-1203 employs a diaphragm pump.
The Laparo-Thoraco Videoscope XLTF-VAW is designed to be used with a VISERA video system center OTV-S7V, light source, documentation equipment, video monitor, endo-therapy accessories, electrosurgical unit and other anciliary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. Olympus has clearance of this system under K053382
ર Indications for Use
The Endoscopic CO2 Regulation Unit UCR is indicated for use as an accessory to the Olympus XLTF-VAW Laparo-thoraco Videoscope and other ancillary equipment for CO2 gas and water feeding to clean the distal lens during endoscopic surgery.
Comparison of Technological Characteristics ર્ણ
The UCR is basically identical to the predicate device in intended use, and similar in specifications except for the feeding gas, feeding pressure indicator and timer function. Comparison between the subject and predicate devices is shown in Table 1.
2
Table 1. Comparison of Specifications Subject Device: Endoscopic CO2 Regulation Unit UCR Predicate Device: Air/Water Supply Pump Unit MAJ-1203 (K053382)
The following table is a comparison between the subject device and predicate device.
| Items | Subject Device | Predicate Device |
|---|---|---|
| UCR | ||
| Endoscopic CO2 Regulation Unit | MAJ-1203 | |
| Air/Water Supply Pump Unit | ||
| 510(k) Number | - | K053382 |
| Dimensions (WxDxH) | 130(w) x 156(H) x 334(D) (mm) | 85(w) x 155(H)x 191(D) (mm) |
| Feeding gas | CO2 | Air |
| Feeding method | Decompression valve | Diaphragm pump |
| Feeding pressure indicator | Five level LED indication | None |
| Timer function | Provided | None |
7 Conclusion
When compared to the predicate device, the Endoscopic CO2 Regulation Unit does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three swooping lines representing the flow of life and health. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2008
Ms. Laura Storms-Tyler Vice President Regulatory Affairs and Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K081173
Trade/Device Name: Endoscopic CO2 Regulation Unit UCR Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: December 4, 2008 Received: December 5, 2008
Dear Ms. Storms-Tyler:
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 idenotions 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 Amendmouts 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 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, l'isting 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 such additional controls. Existing major regulations affecting your it it vine 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.
4
Page 2
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.
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 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;
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
K08 1173
Device Name: UCR
Indications for Use:
ENDOSCOPIC CO2 REGULATION UNIT UCR
This instrument has been designed to be used with Olympus XLTF-VAW Laparo-Thoraco Videoscope and other ancillary equipment for CO₂ gas and water feeding to clean the distal lens during endoscopic surgery.
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)
Helmut Lense
Page 1 of ___1
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev
510(k) Number K08