(74 days)
Not Found
No
The summary describes a device for insufflation (gas and water feeding) during endoscopy, with no mention of AI, ML, image processing, or data analysis capabilities.
No
The device is used to distend the gastrointestinal tract for optimal endoscopic observation, which is a diagnostic or procedural aid, not a therapeutic intervention.
No
Explanation: The device is used to distend the gastrointestinal tract with CO2 gas and water for better endoscopic observation, which is a preparatory step for an endoscopic procedure, not a diagnostic act in itself.
No
The device description clearly indicates it is a hardware device (Endoscopic Insufflation Unit model XECR-2) used for CO2 gas and water feeding, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to distend the gastrointestinal tract with CO2 gas and water feeding to optimize endoscopic observation. This is a therapeutic or procedural support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms its function is to provide CO2 gas for insufflation during endoscopy. This is a medical device used during a procedure, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), any diagnostic testing, or any output related to disease diagnosis or monitoring based on sample analysis.
Therefore, the Endoscopic Insufflation Unit model XECR-2 is a medical device used to facilitate an endoscopic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.
Product codes (comma separated list FDA assigned to the subject device)
FCX and KOG
Device Description
The Endoscopic Insufflation Unit model XECR-2 is used to distend the gastrointestinal tract to optimize endoscopic observation utilizing carbon dioxide gas. The XECR-2 can be connected to both a CO2 cylinder and the medical facilities gas pipeline facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal 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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K 063786
510(k) SUMMARY
Endoscopic Insufflation Unit model XECR-2
2006/10/**
் போட்டிக்
1-3 : 66 V
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
Executive Director
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610, USA
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 No: 3002808148 |
2 Device Identification
| Device Trade Name: | Endoscopic Insufflation Unit model XECR-2 |
|---|---|
| Common Name: | Endoscopic Insufflator |
| Regulation Number: | 21 CFR No. 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology and urology |
| Product Code: | FCX and KOG |
1
K063786
Vg 2 "7"2
Predicate Device Information 3
| Device Name | Olympus-Keymed Endoscopic CO₂ Regulator, Model ECR | E-Z-EM Endoscopic CO₂ Regulator |
|---|---|---|
| Common Name | Endoscopic Insufflator | Endoscopic Insufflator |
| Manufacturer | KeyMed, Ltd. | E-Z-EM, Inc. |
| 510(k) No. | K881004 | K053008 |
4 Device Description
The Endoscopic Insufflation Unit model XECR-2 is used to distend the gastrointestinal tract to optimize endoscopic observation utilizing carbon dioxide gas. The XECR-2 can be connected to both a CO2 cylinder and the medical facilities gas pipeline facility.
5 Indications for Use
This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.
6 Comparison of Technological Characteristics
The Endoscopic Insufflation Unit model XECR-2 is basically identical to the predicate devices in intended use, and similar in specifications except for the addition of new functions such as a timer. The clinical literature provided in this submission support the safety and efficacy of the subject device.
7 Conclusion
When compared to the predicate devices, the XECR-2 insufflation 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.
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized graphic of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the graphic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K063786
Trade/Device Name: Endoscopic Insufflation Unit model XECR-2 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: December 19, 2006 Received: December 26, 2006
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 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.
MAR 0 5 2007
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.
Image /page/2/Picture/9 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal in a large, bold font. Below the letters "PA" is the word "Centennial". There are three stars below the word "Centennial". The text "100 Years of Progress" is at the bottom of the seal.
Protecting and Promoting Public Health
3
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.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
4
Indications for Use
Ko63786 510(k) Number (if known): Device Name: Endoscopic Insufflation Unit model XECR-2 Indications For Use:
This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO2 gas and water feeding.
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)
Nancy C. Broadon
(Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices 510(k) Number
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