(57 days)
MD-431
None
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML.
No
The device is described as supplying sterile water to endoscopes, facilitating the endoscope's function rather than providing a direct therapeutic effect on a patient. Its purpose is to assist in the operation of another medical device.
No
This device is designed to supply sterile water to endoscopes, facilitating their operation, not to identify or determine the nature of a disease or condition. It is an accessory for an existing medical device (endoscope), not a diagnostic tool itself.
No
The device description clearly details physical components (tubes, fittings, bottle cap adapter) and their mechanical function in delivering sterile water. There is no mention of software as part of the device itself.
Based on the provided information, the Endo SmartCap™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to supply sterile water to endoscopes. This is a function related to the operation and cleaning of a medical device (the endoscope), not for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a mechanical device for transferring fluid and air. It does not involve reagents, calibrators, control materials, or any components typically associated with in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
- Mentioning any analytical performance metrics (sensitivity, specificity, etc.)
The Endo SmartCap™ is a medical device that facilitates the use of an endoscope by providing sterile water for irrigation or other procedures during the endoscopic examination. It is an accessory to the endoscope, which is a diagnostic tool, but the SmartCap itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
Product codes
KOG
Device Description
The Endo SmartCap™ consists of two tubes, arranged coaxially, with a fitting on one end and a hottle cap adapter on the other. On one end, the tubes engage a coaxial fitting designed to replicate the fitting of the predicate device and how it engages with the receptacle on the Endoscope. The fitting is designed to receive air from the Endoscope and direct the flow through the annulus between the inner and outer tubes. The opposite end of the outer tube is connected to a bottle cap adapter by means of a compression fitting to form an airtight scal. The inner tube passes through the compression fitting and extends beyond the cap adapter. When assembled with a bottle of sterile water, the device allows air from the Endoscope to pressurize the bottle and motivate water out of the bottle through the inner tube. The inner tube terminates at the coaxial fitting where water is directed through a separate channel of the receptacle to feed the Endoscope.
The Endo SmartCap™ is sold as a sterile, single patient use device. It will be individually packaged in a Chevron-style sterile barrier pouch with the product label affixed to the clear side of the package, or the label pre-printed on the Tyvek® side of the pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Bench Testing: Bench testing of the applicant's device and the predicate device was performed using the same Endoscope system and in a manner which emulates the product in use. The two output variables which are the subject of this test were water flow rate and static pressure rating.
Flow Test Results: Flow rate tests demonstrate that the applicant's device delivers the same flow rate under a variety of pressure settings as the predicate device, within reasonable measurement error (+/-4%).
Pressure Test Results: According to the Olympus Endoscope manual, the air pump is rated to produce a maximum of 0.32 kg/cm- (4.4 PSI). The applicant's device was tested to 10 PSI using sterile water bottles from the three largest sterile water manufacturers (Abbott, Baxter and McGaw) without leaking or any other failure.
Key Metrics
Not Found
Predicate Device(s)
Olympus Model Number MD-431 Water Container
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
12 Pin I
Endo SmartCap™ Company
16800 Imperial Valley Drive, Suite 312 Houston, TX 77060 (281) 999-4442 (713)445-0019 FAX
Contact Person: Date this summary was prepared: Mr. Don Byrne, President March 13, 1997
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is _ _ ____________________________________________________________________________________________________________________________________________
| 1. Trade Name: | The Endo Smart Cap™ |
|---|---|
| Common Name: | Sterile Water Bottle Adapter |
| Classification Name: | Endoscopes and Accessories |
- Predicate Device: The Endo SmartCap™ is substantially equivalent to a device currently in commercial distribution and marketed in the United States by
Olympus America Inc.
Two Corporate Center Drive
Melville, NY 11747-3157
as the Olympus Model Number MD-431 Water Container. The Olympus MD-431 Water Container is sold as part of the Olympus Series Number 10, 100 or 130 Endoscope and accessories.
1
1
K971125
PLng5
16800 Imperial Valley Drive, Suite 312 Houston, TX 77060 (281) 999-4442 (713)445-0019 FAX
Endo SmartCap™ 510(k) Summary of Safety and Effectiveness March 13. 1997
Page 2 of 5
The Endo SmartCap™ consists of two tubes, arranged coaxially, 3. Description: with a fitting on one end and a hottle cap adapter on the other. On one end, the tubes engage a coaxial fitting designed to replicate the fitting of the predicate device and how it engages with the receptacle on the Endoscope. The fitting is designed to receive air from the Endoscope and direct the flow through the annulus between the inner and outer tubes. The opposite end of the outer tube is connected to a bottle cap adapter by means of a compression fitting to form an airtight scal. The inner tube passes through the compression fitting and extends beyond the cap adapter. When assembled with a bottle of sterile water, the device allows air from the Endoscope to pressurize the bottle and motivate water out of the bottle through the inner tube. The inner tube terminates at the coaxial fitting where water is directed through a separate channel of the receptacle to feed the Endoscope.
The Endo SmartCap™ is sold as a sterile, single patient use device. It will be individually packaged in a Chevron-style sterile barrier pouch with the product label affixed to the clear side of the package, or the label pre-printed on the Tyvek® side of the pouch.
-
- Intended Use: The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
2
16800 Imperial Valley Drive, Suite 312 Houston, TX 77060 (281) 999-4442 (713)445-0019 FAX
Endo SmartCap™ 510(k) Summary of Safety and Effectiveness March 13, 1997
Page 3 of 5
- న్. Summary of Technological Characteristics:
- ર . I The predicate device consists of a system comprised Design: of a refillable plastic water bottle made of autoclavable materials, and a bottle cap/tube set/connector assembly which, together as a set, are designed to be cleaned, disinfected, autoclaved, and reused. According to the manufacturer's Instructions for Use (see Attachment "F"), the predicate device's manufacturer requires the user to " ... Maintain the water container daily. The water container should be emptied, cleaned, and disinfected or sterilized at least once per day. Water bottles which are not maintained property (properly) may present an infection control risk."
The Endo SmartCap™ consists of a bottle cap/tube set/connector made of materials which are appropriate for the application, but are selected for single use, only. The applicant's device fits the three largest U.S. sterile water suppliers' bottles (sold by Abbott Laboratories, McGaw, and Baxter Healthcare). By attaching the Endo SmartCap™ to the sterile water bottle, the applicant's device becomes a replacement for the predicate device. By replacing a reusable device with a single use, disposable device, the risks associated with cross-contamination -- which are inherent with reusable devices -- are eliminated.
3
16800 Imperial Valley Drive, Suite 312 Houston, TX 77060 (713)445-0019 FAX (281) 999-4442
Endo SmartCap™ 510(k) Summary of Safety and Effectiveness March 13, 1997
Page 4 of 5
- Sterilization: The predicate device is intended for autoclave sterilization 5.2 by the user, while the Endo SmartCap™ is sterilized by Ethylene Oxide and is sold sterile as a single patient use device.
-
- Performance
- 6.1 Bench Testing: Bench testing of the applicant's device and the predicate device was performed using the same Endoscope system and in a manner which emulates the product in use. The two output variables which are the subject of this test were water flow rate and static pressure rating.
- Flow rate tests demonstrate that the 6.2 Flow Test Results: applicant's device delivers the same flow rate under a variety of pressure settings as the predicate device, within reasonable measurement error (+/-4%).
- 6.3 According to the Olympus Pressure Test Results: Endoscope manual, the air pump is rated to produce a maximum of 0.32 kg/cm- (4.4 PSI). The applicant's device was tested to 10 PSI using sterile water bottles from the three largest sterile water manufacturers (Abbott, Baxter and McGaw) without leaking or any other failure.
4
PS975
16800 Imperial Valley Drive, Suite 312 Houston, TX 77060 (281) 999-4442 (713)445-0019 FAX
Endo SmartCap™ 510(k) Summary of Safety and Effectiveness March 13, 1997
Page 5 of 5
6.3 Justification of Determination of Substantial Equivalence
The Endo SmartCap™ differs from the predicate device in design, materials and sterilization methods, however the performance of the two devices in use are quite similar. Although the materials of construction are different from the predicate, the differences are justifiable when the reusable versus disposable application is taken into consideration, and no new questions are raised regarding safety and effectiveness.
7. Conclusion
The Endo SmartCap™ was tested and proven to withstand at least twice the static pressure the Endoscope air pump is capable of delivering. In flow tests, the Endo SmartCap™ delivered a flow rate which was indistinguishable from the predicate device without precision measurement techniques. It was therefore concluded that the Endo SmartCap™ demonstrated equivalency in its performance as compared to the predicate device.
Don Byrne, President Date
3-18-97
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 1997
Mr. Don Byrne President Endo SmartCap™ Company 16800 Imperial Valley Drive, Suite 312 Houston, Texas 77060
Re: K971125
The Endo SmartCapTM Sterile Water Bottle Adaptor . ...................................... Dated: March 18, 1997 Received: March 27, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG
Dear Mr. Byrne:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 53 1 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Xin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproducts Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K 971125 |
| Device Name: | Endo SmartCap TM Sterile Water Bottle Adaptor |
MAY-22-19
The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.
maran mi
Concurrence of CDRH, Office of Device Evaluation
(ODE)
Robert R. Sather/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_1(9711 = 5
510(k) Number
Prescription Use _
Counter Use _
(Per 21 CFR 801.109)
OP
Over-The-
Optional Format
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