The Opt-Shield AIR Convection Warming technology is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patient to become too cold.

Device Description

Proposed device: Opt-Shield™ AIR. SAFE Patient-Handling System for Surgical Patient: The proposed Opt-Shield AIR blanket consists of three layers of material: bottom layer nylon impermeable to air (non-contact), middle layer plastic with predetermined holes (non-contact), and top layer polypropylene (in contact with the patient) with microscopic holes (intrinsic to the fabric) throughout the fabric. The three layers are sewn together to create air channels to allow air distribution evenly throughout the blanket to minimize heat reduction. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. It has one hose port for receiving warm air.

AI/ML Overview

The provided text describes a 510(k) submission for the Opt-Shield™ AIR convective warming blanket, comparing it to a predicate device, the 3M Bair Hugger™ Temperature Management Blanket. The studies described are non-clinical bench tests comparing the performance of the proposed device to the predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device. The study aimed to demonstrate "substantially similar" performance.

Acceptance Criteria (Implied)	Reported Device Performance (Opt-Shield™ AIR vs. 3M Bair Hugger™)
Surface Temperature performance is substantially similar	Surface temperatures are substantially similar
Internal Temperature performance is substantially similar	Internal temperatures are substantially similar
Internal Airflow performance is substantially similar	Internal Airflows are substantially similar
Internal Pressure performance is substantially similar	Internal pressures are substantially similar
Durability and Integrity for at least 8 hours at highest heat setting (43°C)	All sealed lines and fabric integrity completely intact after 8 hours of testing

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states, "each of the Opt-Shield AIR samples were also tested." This implies multiple units were tested, but a specific number for the test set is not provided.
Data Provenance: The study was an internal testing performed by BCG Medical, LLC. The country of origin is not explicitly stated, but BCG Medical is based in San Diego, California, USA, suggesting the data provenance is from the USA. The study is non-clinical, so the terms "retrospective" or "prospective" as typically applied to human trials are not directly applicable. These are bench test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described study is a non-clinical bench test evaluating physical performance parameters (temperature, airflow, pressure, durability) against a predicate device. It does not involve human interpretation or expert opinion to establish a "ground truth" in the way, for example, a diagnostic imaging device would and is not listed in the document.

4. Adjudication Method for the Test Set

This section is not applicable as the described study is a non-clinical bench test of physical performance parameters. There is no mention of adjudication, which is typically used for subjective assessments by multiple human readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a convective warming blanket, not an AI or diagnostic imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical device (convective warming blanket), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study was the performance of the legally marketed predicate device (3M Bair Hugger™ Temperature Management Blanket, Full Access Underbody, model 635) under the same test conditions, using the same heat source (Bair Hugger/3M Warming Unit Model 775). The goal was to prove "substantially similar" performance.

8. The Sample Size for the Training Set

This section is not applicable. The described study is a non-clinical bench test for a physical device, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that suggest movement or flow.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BCG Medical, LLC Ms. Lisa Giap Director of Operations 6715 Rancho Toyon Place San Diego, California 92130

Re: K162562

Trade/Device Name: Opt-Shield™ AIR Supine, Opt-Shield™ AIR Lithotomy Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: December 19, 2016 Received: December 19, 2016

Dear Ms. Giap:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162562

Device Name Opt-Shield AIR Supine, Opt-Shield AIR Lithotomy

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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XPrescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for BCG Medical. The logo consists of two interlocking cubes, one in shades of gray and the other in shades of blue. Below the cubes, the text "BCG" is written in a simple, sans-serif font, with the "BC" in black and the "G" in a lighter gray. Below "BCG", the word "MEDICAL" is written in smaller, all-caps letters.

BCG Medical, LLC 6715 Rancho Toyon place, San Diego, CA 92130 Phone: 800-998-7087 www.bcgmedical.com

Traditional 510(k) Submission Summary, K162562

DATE PREPARED: September 6th, 2016 DATE REVISED: March 6th, 2016

GENERAL INFORMATION

Applicant's Name: BCG Medical, LLC Address: 6715 Rancho Toyon place San Diego, CA 92130 Website: www.bcgmedical.com Phone: 858-349-1331 Fax: 858-869-0899 Registration Number: 27-3718418 Contact Person: Lisa Giap Email: Lisa@bcgmedical.com

Device names:

Trade Name: 1) Opt-ShieldTM AIR Supine (Proposed device) 2) Opt-Shield™ AIR Lithotomy (Proposed device) Common/Usual Name: Convective Warming Blanket

Regulation Number: 21 CFR 870.5900 Classification Name: Thermal Regulating System (21CFR 870.5900, Product Code DWJ)

Reason for the 510(k): BCG Medical has added an additional function, the Convective Warming Function, a class 2 classification, to our currently class 1 marketed device, the Opt-Shield Supine and Opt-Shield Lithotomy.

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Image /page/4/Picture/0 description: The image shows the logo for BCG Medical. The logo consists of two overlapping squares, one in a light blue color and the other in a dark gray color. Below the squares, the text "BCG MEDICAL" is written in a simple, sans-serif font, with "MEDICAL" in a smaller font size than "BCG".

Predicate: 3M Bair Hugger™ Temperature Management Blanket, Full Access Underbody, model 635 (Predicate K001149)

Proposed Opt-Shield AIR comprises of the following devices: (Trade Names)

Opt-Shield™ AIR Supine (blue and white)
Opt-Shield™ AIR Lithotomy (blue and white)

Device description:

Predicate:

3M Bair Hugger, Temperature Management Blanket, Full Access Under body, model 635 (Predicate K001149). It is made of two lavers of non- woven laminated tissue fabric. The layers are glued (or bonded) together to form a network of air channels. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. The model 635 comes with two (2) hose ports for receiving warm air. Proposed device:

Opt-Shield™ AIR. SAFE Patient-Handling System for Surgical Patient:

The proposed Opt-Shield AIR blanket consists of three layers of material: bottom layer nylon impermeable to air (non-contact), middle layer plastic with predetermined holes (non-contact), and top layer polypropylene (in contact with the patient) with microscopic holes (intrinsic to the fabric) throughout the fabric. The three layers are sewn together to create air channels to allow air distribution evenly throughout the blanket to minimize heat reduction. The warm air circulates within blanket and delivers warm air around the patient's body through perforations in the patient side layer of the blanket. The distribution of air is designed to equally deliver air at the similar temperature air at various blanket locations. It has one hose port for receiving warm air.

Indications for Use:

Technological characteristics:

Predicate: Two layers of non-woven laminated tissue fabric, polypropylene and polyethylene, network of channels created by heat sealing to allow even heat distribution

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Image /page/5/Picture/0 description: The image shows the logo for BCG Medical. The logo consists of two overlapping cubes, one in light gray and the other in light blue. Below the cubes, the text "BCG MEDICAL" is written in a simple, sans-serif font, with "BCG" on the top line and "MEDICAL" on the bottom line.

throughout the blanket. It has two air inlets.

Proposed Opt-Shield AIR: Two layers of non-woven laminated tissue fabric, polypropylene and polyethylene plus a third laver of nylon fabric that is not in contact with the patient, and network of channels created by sewing the three layers to allow even heat distribution throughout the blanket. It has one air inlet.

Summary of the main non-clinical test results:

The purpose of this internal testing is to compare the effectiveness of heat distribution performances inside and on the surface, internal airflow performances, pressure performances and durability performances of the convective warming blanket of the Opt-Shield AIR (OSA) by BCG Medical in comparison to the Bair Hugger (BH) Full Access Underbody Blanket (Predicate) using the same heat source, the Bair Hugger/3M Warming Unit Model 775.

In addition, each of the Opt-Shield AIR samples were also tested for durability and integrity for at least 8 hours continuously with the warming unit running at highest heat setting (43 degree C). They were then carefully inspected for any damages. All the sealed lines and the fabric integrity were completely intact after the 8 hours of Test of Durability and Integrity.

Finding summary: Surface temperatures, Internal temperatures, Internal Airflows and Internal pressures are substantially similar. We concluded that the Opt-Shield AIR convective warming blanket is substantially equivalent to Bair Hugger Full Access Underbody blanket in performance in terms of surface temperature, internal temperature, internal airflow, internal pressure and durability.

Conclusion:

The Opt-Shield AIR is classified as class II and is substantially equivalent to the predicate device, the 3M Bair Hugger Temperature Management System, Full Access Underbody blanket (Predicate K001149), based on comparisons of the device classifications, intended use, and technological characteristics.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).