(290 days)
The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.
The Flexiblade™ is a rigid laryngoscope featuring a flexible blade. The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free. This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.
The provided text describes a 510(k) submission for the Flexiblade™ - Flexible Laryngoscope. This is a Class I (exempt) device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria through a detailed study with acceptance criteria.
Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, and statistical analyses are not applicable or cannot be extracted from this type of regulatory document.
Here's an analysis of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or quantified device performance metrics are provided in the document. The substantial equivalence claim is based on a series of performance testing and clinical experience, but the details of these tests and their outcomes against pre-defined criteria are not disclosed in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No quantitative performance reported in this document beyond being substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "a series of performance testing and clinical experience" without indicating the number of subjects, cases, or tests conducted.
- Data Provenance: Not specified. It's unclear if the "clinical experience" or "performance testing" was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of analysis is common for diagnostic algorithms, but not for a physical device like a laryngoscope demonstrating substantial equivalence.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or described. This type of study comparing human readers with and without AI assistance is not relevant to a physical medical device like a laryngoscope.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical instrument, not an algorithm, so a "standalone" algorithmic performance study is irrelevant.
7. Type of Ground Truth Used:
Not applicable in the context of an "algorithm" or "diagnostic" ground truth. For a physical device demonstrating substantial equivalence, the "ground truth" would be its functional performance in comparison to predicate devices and general safety/effectiveness considerations. The document indicates this was evaluated through "performance testing and clinical experience" against "voluntary standards ASTM F965-85 and ISO 7376-1."
8. Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is not an AI algorithm.
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11984101
SEP | 3 |1999
510(K) SUMMARY
Flexiblade™ -Flexible Laryngoscope
510(k) Number K ____________
Applicant's Name:
Arco Medic, Ltd. Omer Industrial Park Bldg. 8 Omer 84659, Israel Tel: 972-7-6499466 Fax: 972-7-6499488
Contact Person:
Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131
Date Prepared:
November 11, 1998
Trade Name:
Flexiblade™ - Flexible Laryngoscope
Classification Name:
Rigid Laryngoscope
Classification:
Product Code CCW, Class I (exempt)
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Predicate Device:
The Flexiblade™ is substantially equivalent to the Welch Allyn Fiber Optic Laryngoscope Model 60813 with Macintosh blade, cleared under K831981, and the Truphatek Fiber Optic Laryngoscope with Macintosh blade, cleared under K883414.
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the Flexiblade™ complies with the voluntary standards ASTM F965-85 and ISO 7376-1.
Indication for Use:
The Flexiblade™ is intended for use as an aid for placement of tracheal tube, and for examination and visualization of patient's upper airway.
Device Description:
The Flexiblade™ is a rigid laryngoscope featuring a flexible blade.
The flexibility of the blade is achieved as a result of the motion of a trigger on the larvngoscope handle that its front end is fixed to the front part of the blade and its rear end is free.
This control over the blade flexibility allows the operator performing intubation to place the blade end exactly in the vallecula area elevating the epiglottis with his/her fingers (by gently squeezing the trigger) without changing the device position.
Substantial Equivalence:
Based on a series of performance testing and clinical experience. Arco Medic Ltd. believes that the Flexiblade™ is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 3 1999
Ms. Shoshana Friedman General Manager ArcoMedic Ltd. c/o Push-Med, Inc. 117 Ahuza Street Ra'ananna 43373 Israel
Re: K984101 Flexiblade™ Laryngoscope Requlatory Class: I (one) Product Code: 73 CCW Dated: June 5, 1999 Received: June 8, 1999
Dear Ms. Friedman:
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 leqally 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). 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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 requlatory 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Shoshana Friedman
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. CallaMan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
1-984101 510(k) Number (if known):
Device Name:
Flexiblade™- Flexible Laryngoscope
Indications for Use:
The Flexiblade™ - Flexible Laryngoscope is intended for use as an aid for placement of tracheal tube and examination and visualization of patient's upper airway.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number
Prescription Use (Per 21 CFR 801.109)
ﺳ
OR
Over the Counter Use
M. R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9