SMART BITEBLOC

K042665 · Oridion Medical 1987 , Ltd. · CCK · Nov 23, 2004 · Anesthesiology

Device Facts

• Record ID: K042665
• Device Name: SMART BITEBLOC
• Applicant: Oridion Medical 1987 , Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).

Device Story

Smart BiteBloc is an endoscopy accessory designed to hold a bite block while integrating an oral nasal cannula (K011536). Device allows simultaneous EtCO2 sampling and supplemental oxygen delivery during endoscopic procedures. Used in clinical settings by healthcare providers; device supports patient monitoring without interfering with airway management. Benefits include improved convenience and safety for non-intubated patients requiring capnography during endoscopy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bite block accessory with integrated routing for oral nasal cannula. Mechanical design facilitates simultaneous capnography and oxygen delivery. No software or electronic components.

Indications for Use

Indicated for non-intubated patients >55 lbs (25 kg) undergoing endoscopy procedures requiring a bite block; facilitates use of oral nasal cannula for EtCO2 sampling and supplemental O2 administration.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• United States Endoscopy (K954352)
• United States Endoscopy (K924304)
• Endoscopix Bite Block (K896691)
• GI Supply Bite Block (K915816)
• GI Supply Oxy-Block (K931044)
• Stantex Pty Ltd Oxiguard (K914978)

Submission Summary (Full Text)

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## NOV 2 3 20 2. Modified 510(k) Summarv

## To Incorporate Bite Block Classification and Product Code

# 7.0 510(k) Summary of Safety and Effectiveness Information (This document is not confidential)

## PRODUCT NAME

Proprietary: Smart BiteBloc TM

Common: Bite Lock Endoscopy/Capnography Accessory

#### ESTABLISHMENT REGISTRATION NUMBER

Establishment Registration Number: 3003941644

### ESTABLISHMENT ADDRESS:

Oridion Capnography Inc.

21 Highland Circle

Needham, MA 02494-3038

## CONTACT PERSON:

Sanford Brown, Regulatory Affairs Director

Oridion Medical 1987 Ltd.

Har Hotzvim Science Based Industrial Park

POB 45025

91450 Jerusalem, Israel

Telephone: [phone]

FAX: [phone]

## DEVICE LISTING FDA FORM 2892:

B051971

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#### DEVICE DESCRIPTION

Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.

#### SUBSTANTIAL EQUIVALENCE INFORMATION

#### Predicate Devices

United States Endoscopy K954352

United States Endoscopy K924304

Endoscopix Bite Block K896691

Gl Supply Bite Block K915816

GI Supply Oxy-Block K931044

Stantex Pty Ltd Oxiguard K914978

The Smart BiteBloc™ has the same intended use as the predicate devices identified in this section. Any technological differences with the predicate devices do not raise any new questions regarding safety and effectiveness. Therefore, Oridion considers the Smart BiteBloc to be substantially equivalent to the predicate devices.

#### PRODUCT CLASSIFICATION

73CCK Class II

21 CFR 868.1400, carbon dioxide analyzer

## The BiteBloc™ itself is normally classified according to 21CFR876.1500 as follows:

Class I

Product Code MNK

#### INTENDED USE

The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).

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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 perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Mr. Sandy Brown Regulatory Affairs Director Oridion Medical 1987 Limited 7 Hamarpe Street Jerusalem, 91450 ISRAEL

Re: K042665

Trade/Device Name: BiteBlocTM Regulation Number: 868.1400 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCK, MNK Dated: September 27, 2004 Received: September 29, 2004

Dear Mr. Brown:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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Page 2 - Mr. Brown

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 (OS) 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 vour 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 [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Culs

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Supplementary Submission BiteBlock K042665 Reply to FDA Questions of November 5, 2004 Modified Indications for Use Statement

## 2. Modified Indications for Use Statement

This document is not confidential

November 11, 2004

Device Name:

BiteBloc™

Indications For Use:

The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Acee Sullivans

(Division of Anesthesiology, General Hospital, Infection Control, De

510(k) Number:_

OR