(309 days)
The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.
The provided 510(k) summary for K970107, the UROHEALTH Intubation Endoscope and Introducer Sheath, describes performance testing but does not present specific acceptance criteria or detailed study results in a quantitative manner as typically expected for device performance. It outlines the types of tests to be conducted rather than reporting the outcomes against defined metrics.
Here's a breakdown based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria and reported device performance are not available. The summary states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of sterile barrier under normal usage conditions | "will be tested to ensure integrity of the sterile barrier under normal usage conditions." (No specific results or metrics provided). |
| Integrity of all bonded joints based on appropriate ASTM procedure | "All bonded joints will tested according to the appropriate ASTM procedure." (No specific results or metrics provided). |
| Biocompatibility (cytotoxicity, sensitization, irritation) in accordance with EN 30993 for medical devices with mucosal membrane contact (<24 hours) | "Biocompatibility testing will be conducted on both component level and finished devices (sterile, if applicable). This testing will include but is not limited to cytotoxicity, sensitization, and irritation. The device is considered body contact surface of mucosal membranes for a limited (less than 24 hours) contact duration. This testing is in accordance with EN 30993 for medical Devices." (No specific results or metrics provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify any sample sizes for the performance, integrity, or biocompatibility tests.
- Data Provenance: The document does not specify the country of origin of the data, nor whether the studies are retrospective or prospective. It only mentions that the testing "will be conducted," implying prospective testing.
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)
This device is a medical instrument (bronchoscope/endoscope) for direct visualization, not an AI or diagnostic imaging device that requires interpretations of images by experts to establish ground truth. Therefore, these criteria are not applicable to this type of submission. Performance testing here refers to engineering and biological safety tests, not clinical or diagnostic accuracy studies involving expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This criterion is not applicable as it relates to expert review for diagnostic/interpretive devices, which this is not. The performance tests described (sterile barrier, bonded joints, biocompatibility) would have specific pass/fail criteria for each test without an adjudication method.
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
This is not applicable. This device is a direct visualization tool, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI improvement statistics would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical invasive medical instrument; there is no "algorithm only" component.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the tests mentioned:
- Sterile Barrier & Bonded Joints: The "ground truth" would be the successful integrity of the materials and seals as per defined engineering specifications and ASTM standards.
- Biocompatibility: The "ground truth" would be the absence of adverse biological responses (cytotoxicity, sensitization, irritation) as per the EN 30993 standard.
This is not a diagnostic device requiring a "ground truth" for interpretation.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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510(k) SUMMARY
In accordance with the requirements of SMDA 1990 and 21 CFR 807.92 this in accordanos with the required Effectiveness is submitted with the Premarket Submission.
| Company Name: | UROHEALTH Systems, Inc.3050 Redhill Ave.Costa Mesa, CA 92626 | NOV 18 1997 |
|---|---|---|
| Contact Person:Telephone Number: | Ronald Bergeson714.708.7748, ext. 248 | |
| Device Name: | Bronchoscope | |
| Proprietary Device Name: | Intubation Endoscope andIntroducer Sheath | |
| Classification Name: | Bronchoscope (flexible or rigid) andaccessories | |
| Predicate Devices: | SteBar Instr. Corp. Schroeder Oral/NasalStylette™ | |
| Vision-Sciences EndoSheath® | ||
| AMERICAN OPTICAL FlexibleBrochoscope FBS-1 | ||
| Karl Storz Intubation Fiberscope | ||
| Device Description: | UROHEALTH Intubation Endoscope IntroducerSheath is a device that consists a malleable ornonmalleable introducer sheath that houses achannel for insufflation of oxygen or fluiddelivery, a deflecting mechanism for the distaltip, a channel for scope insertion, and a distalwindow. The reusable fiber optic imaging andillumination system consists of a focusingocular lens, a distal objective lens, and aconnection for a fiber optic light cable. |
Image /page/0/Picture/4 description: The image shows a sequence of numbers. The numbers are 000048. The first four numbers are zeros, followed by the numbers four and eight.
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| Intended Use: | The Intubation Endoscope and IntroducerSheath are used in the direct visualization inthe trachea and lungs during fiberopticallyassisted intubation and airway management. |
|---|---|
| Performance Testing: | The Intubation Endoscope and IntroducerSheath will be tested to ensure integrity ofthe sterile barrier under normal usageconditions. All bonded joints will testedaccording to the appropriate ASTMprocedure. |
| Biocompatibility: | Biocompatibility testing will be conducted onboth component level and finished devices(sterile, if applicable). This testing will includebut is not limited to cytotoxicity, sensitization,and irritation. The device is considered bodycontact surface of mucosal membranes for alimited (less than 24 hours) contact duration.This testing is in accordance with EN 30993 formedical devices. |
| Substantial Equivalence: | Based on the indications for use, technologicalcharacteristics, and safety and performancetesting to be completed, the UROHEALTHIntubation Endoscope and Introducer Sheathwill be shown to be safe and effective for itsintended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1997
Ronald Bergeson Corporate Director, Regulatory Affairs Imagyn (formerly UroHealth) 5 Civic Plaza Suite 100 Newport, CA 92660
Re:
K970107 Intubation Endoscope and Introducer Sheath Dated: October 7. 1997 Received: October 8, 1997 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO
Dear Mr. Bergeson:
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, 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 542 of the Act for devices under 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) 594-4613. 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,
W. Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| (if known): | K970107 |
|---|---|
| ------------- | --------- |
Intubation Endoscope and Introducer Sheath Device Name:
Indications for Use:
510 (k) Number (if
The Intubation Endoscope is used for direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.1091 OR
Over-The-Counter Use
(Optional Format 1-2-96)
Olin L. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deviçes 0107 510(k) Number .
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.