WATCH-PAT MODEL 100S-2

K080427 · Itamar Medical · MNR · May 23, 2008 · Anesthesiology

Device Facts

• Record ID: K080427
• Device Name: WATCH-PAT MODEL 100S-2
• Applicant: Itamar Medical
• Product Code: MNR · Anesthesiology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Watch-PAT100S-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The WP100S-2 is not indicated for children less than 17 years old.

Device Story

Wrist-worn home care device; detects sleep-related breathing disorders and sleep staging. Inputs: peripheral arterial tonometry (PAT) signal via finger probe; blood oxygen saturation via embedded pulse oximeter; motion data via embedded actigraph. Electronics record and process signals to calculate PRDI, PAHI, and sleep stages (PSTAGES). Used by patients in home setting; data reviewed by healthcare providers to assist in clinical decision-making regarding sleep disorders. Benefits include non-invasive, home-based diagnostic assessment.

Clinical Evidence

Clinical study validated accuracy of WP100S-2 in sleep staging and detection of respiratory sleep disorders. Compared against gold-standard PSG, BioSleep (for sleep staging), and WP100S (for respiratory disturbance index). Results established accuracy for sleep staging identification and respiratory indices (PRDI and PAHI).

Technological Characteristics

Wrist-worn device; opto-pneumatic PAT sensor; embedded pulse oximeter; embedded actigraph. Non-latex probe coating. Connectivity: records data to internal electronics. Software-based analysis of PAT signals, oxygen saturation, and motion.

Indications for Use

Indicated for patients >= 17 years old suspected of having sleep-related breathing disorders. Used as a diagnostic aid for sleep staging and detection of respiratory disturbances. Not for use as sole diagnostic basis for treatment prescription.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

• Watch-Pat100S (WP100S) (K042916)
• BioSleep (K002622)
• Silent night II (K981034)
• Embla (K971813)

Submission Summary (Full Text)

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# 510(K) Number K080427

- 5.1 Applicant's Name: Itamar Medical Itd. 2 Ha'eshel st. Caesarea 38900, Israel Tel: [phone] Fax: [phone]
- Jonathan Kahn, Esq. 5.2 Contact Person: Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone] and/or: Dorit Winitz, Ph.D. Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] [e-mail]:
- 5.3 Date Prepared: January 2008
- Watch-PAT 100S-2 ("WP100S-2") 5.4 Trade Name:
- 5.5 Common or Usual Name: Ventilatory Effort Recorder
- 5.6 Classification Name: Breathing Frequency Monitor
- 5.7 Medical Specialty: Anesthesiology
- 5.8 Product Code: Ventilatory Effort Recorder, MNR
- 5.9 Device Class: Class II
- 5.10 Regulation Number: 868.2375

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## 5.11 Panel: Anesthesiology

## 5.12 Predicate Devices:

- Watch-Pat100S ("WP100S") (Itamar Ltd), cleared under K042916; . product code MNR (ventilatory effort recorder).
- BioSleep (Oxford BioSignal's Ltd.), cleared under K002622; product . code GWQ (Electroencephalograph).
- Silent night II (Sleep Solutions Inc.) cleared under K981034; . product code MNR (ventilatory effort recorder).
- Embla (Ferguson Medical) cleared under K971813, product code � GWQ (electroencephalograph)

# 5.12 Intended Use / Indication for Use:

The Watch-PAT100S-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The WP100S-2 is not indicated for children less than 17 years old.

## 5.13 Device Description:

The WATCH-PAT100S-2 System (WP100S-2) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT); a non-invasive technology.

The WP100S -2 device consists of: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger, for measuring blood oxygen saturation; (3) an embedded actigraph, which is used to determine periods

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of sleep based on the motion of the wrist; (4) Electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, and actigraph; (5) the device software; and (6) a power supply.

The device is worn on the wrist, and continuously measures the relative state of the vasomotor activity in the distal part of the finger, by a fingermounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, opto-pneumatic sensor.

#### 5.14 Substantial Equivalence:

#### Intended Use

The intended use of the WP100S-2 is substantially equivalent to the combination of the intended use of its predicates and any minor differences do not alter the intended diagnostic value of the WP100S-2. The claim of sleep staging and breathing disorders indices, PRDI and its derivative PAHI, were supported by both software verification and validation activities and a clinical study.

#### Technological Characteristics and Mode of Operation

The WP100S-2, like its predicate the WP100S, is a ventilatory effort recorder that utilizes PAT technology. The hardware of the WP100S-2 is basically identical to that of the WP100S except that the internal coating of the WP100S-2's PAT probe was modified to a non-latex coating. The WP100S-2's software modifications raise no new issue of safety or effectiveness, as demonstrated through software verification and validation and supportive clinical data.

#### Performance Testing

Software validation testing was conducted to evaluate both the performance of the WP100S-2 System and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS).

A clinical study was conducted to validate the accuracy of the WP100S-2 System in sleep staging identification and detection of respiratory related sleep disorders against both a gold-standard PSG and the predicate device (Biosleep for sleep staging identification and WP100S for respiratory disturbance index). The study results establish the accuracy of the WP100S-2 System in Sleep Staging identification. The study results additionally establish the accuracy of the WP100S-2 System in Sleep Apnea Indices (PRDI and PAHI).

#### Summarv

Based on the performance testing results, including software verification and validation process and the analysis of the similarities and differences,

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Itamar Ltd. believes that the WP100S-2 System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Itamar Medical Limited C/O Mr. Jonathan S. Kahan Regulatory Affairs Consultant Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K080427

Trade/Device Name: Watch-PAT100S-2 (WP100S-2) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 14, 2008 Received: May 14, 2008

Dear Mr. Kahan:

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. Kahan

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 (QS) 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 your 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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# INDICATIONS FOR USE

510(k) Number (if known): K080427

Device Name: Watch-PAT100S-2 (WP100S-2)

Indications for Use:

The Watch-PAT100S-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The WP100S-2 is not indicated for children less than 17 years old.

Over-The-Counter Use Prescription Use V AND/OR :21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number:_ KOPOYZZ