Beddr 200 System

K190399 · Hancock Medical, Inc. · DQA · Aug 5, 2019 · Cardiovascular

Device Facts

• Record ID: K190399
• Device Name: Beddr 200 System
• Applicant: Hancock Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Beddr 200 System is a reusable forehead reflectance sensor indicated for use in measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spotchecking and/or data collection and recording of patients during no motion conditions, who are well perfused, in a home or healthcare environment.

Device Story

Beddr 200 System is a reusable forehead reflectance pulse oximeter. It measures functional oxygen saturation (SpO2) and pulse rate. Device is intended for spot-checking or data collection/recording in well-perfused patients during no-motion conditions. Used in home or healthcare environments. Operates as a sensor to capture physiological signals; data is stored for review. Healthcare providers or patients use the device to monitor oxygenation status. Output assists in clinical assessment of patient respiratory or cardiovascular health.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Reusable forehead reflectance sensor. Measures SpO2 and pulse rate. Designed for use on well-perfused patients under no-motion conditions.

Indications for Use

Indicated for adult and pediatric patients who are well perfused. Used for measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate during no motion conditions in home or healthcare settings.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 5, 2019

Hancock Medical, Inc. Tom Goff Co-Founder, President and CTO 897 Independence Avenue, #3A Mountain View, California 94043

Re: K190399

Trade/Device Name: Beddr 200 System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 10, 2019 Received: July 11, 2019

Dear Tom Goff:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190399

Device Name Beddr 200 System

## Indications for Use (Describe)

The Beddr 200 System is a reusable forehead reflectance sensor indicated for use in measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spotchecking and/or data collection and recording of patients during no motion conditions, who are well perfused, in a home or healthcare environment.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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