FLEXIBLADE

K984101 · Arco Medic , Ltd. · CCW · Sep 3, 1999 · Anesthesiology

Device Facts

• Record ID: K984101
• Device Name: FLEXIBLADE
• Applicant: Arco Medic , Ltd.
• Product Code: CCW · Anesthesiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1

Intended 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.

Device Story

Flexiblade™ is a rigid laryngoscope with a flexible blade; designed to assist in tracheal intubation and upper airway visualization. Device features a handle-mounted trigger mechanism; squeezing trigger adjusts blade curvature to elevate epiglottis and position blade tip in vallecula without requiring repositioning of the entire device. Used by clinicians in clinical settings for airway management. Provides direct visualization of airway structures to facilitate endotracheal tube placement; improves intubation success by allowing precise blade manipulation.

Clinical Evidence

No clinical data provided. Substantial equivalence based on performance testing and clinical experience.

Technological Characteristics

Rigid laryngoscope with flexible blade mechanism. Complies with ASTM F965-85 and ISO 7376-1 standards. Mechanical operation via handle trigger to adjust blade curvature.

Indications for Use

Indicated for use as an aid for tracheal tube placement and for examination and visualization of the upper airway in patients requiring intubation.

Regulatory Classification

Identification

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Predicate Devices

• Welch Allyn Fiber Optic Laryngoscope Model 60813 with Macintosh blade (K831981)
• Truphatek Fiber Optic Laryngoscope with Macintosh blade (K883414)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

## Contact Person:

Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone]

## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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.

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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 _