The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

Device Description

The BiliBlanket Plus High Output Phototherapy System has two modes of operation: phototherapy, used for the treatment of hyperbilirubinemia; and transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting pneumothoraces or hydrocephalus. In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket. The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces.

AI/ML Overview

The provided text describes the 510(k) summary for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System. However, it explicitly states that no clinical or animal testing was necessary to demonstrate safety and effectiveness due to the well-established clinical practice of treating neonatal hyperbilirubinemia with phototherapy. Instead, the device underwent "extensive bench testing."

Therefore, the requested information regarding acceptance criteria based on clinical studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

Here’s a summary based on the provided text, highlighting the absence of the requested data:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Reference to Clinical Study)
Not specified for clinical performance.	Not applicable, as no clinical studies are presented.
Bench Testing (General)	"Extensive bench testing" conducted.
Regulatory Compliance	Requirements of 21 CFR 820, Subpart C (Design Controls) satisfied.
Substantial Equivalence	Found substantially equivalent to predicate devices (Ohmeda - BiliBlanket Plus (original), PEP - Ultra BiliLight, Medela - BiliBed).
No New Safety/Effectiveness Issues	Technological characteristics similar to predicates; do not raise new safety or effectiveness issues.

2. Sample size used for the test set and the data provenance:

Not applicable. No clinical test set details are provided as no clinical studies were performed. The document mentions "extensive bench testing," but details on sample size or data provenance for this testing are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set means no expert ground truth establishment for a clinical study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set was used requiring an adjudication method.

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:

No. An MRMC study was not done, as this device does not involve "human readers" or "AI assistance" in the context of interpretation that would necessitate such a study. It is a medical device for phototherapy and transillumination, not an imaging or diagnostic AI tool.

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

Not applicable. This is a hardware medical device, not an algorithm, so "standalone performance" in the context of AI algorithms is not relevant. The device operates independently for therapy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable for clinical efficacy. For the "extensive bench testing," the ground truth would have been based on engineering specifications and physical measurements (e.g., light intensity, spectrum, electrical safety), not clinical outcomes or expert consensus.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

In summary, the 510(k) summary for the Ohmeda Medical BiliBlanket Plus High Output Phototherapy System focuses on demonstrating substantial equivalence to predicate devices and adherence to design control regulations, rather than presenting clinical trial data. This is explicitly stated due to the established nature of phototherapy for hyperbilirubinemia.

Summary

{0}------------------------------------------------

X993712

Ohmeda Medical BiliBlanket Plus High Output

510(k) Summary

Submitter Information

Alberto F. Profumo, RAC (also contact person) 9065 Guilford Road Columbia, MD 21046-1801 Tel. (410) 381- 4004 Summary prepared on November 2, 1999

Device Name(s)

Classification Names:

. Neonatal Phototherapy Unit
AC- powered Transilluminator ●

Common Names:

Phototherapy Lamp .
. Transilluminator

Proprietary Name:

BiliBlanket Plus High Output Phototherapy System .

Predicate Device Information

The BiliBlanket Plus High Output Phototherapy System is substantially equivalent to the following, legally marketed products:

. Ohmeda - BiliBlanket Plus (original)
. PEP - Ultra BiliLight
. Medela - BiliBed

Indications for Use

Product Description

The BiliBlanket Plus High Output Phototherapy System has two modes of operation:

phototherapy, used for the treatment of hyperbilirubinemia; and a)
transillumination, used for a variety of medical procedures such as locating venipuncture sites and detecting b) pneumothoraces or hydrocephalus.

In the phototherapy mode, a fiberoptic cable and blanket are attached to the illuminator box. Phototherapeutic light, which is light in the blue region (400 - 550 nm), is transmitted from the blanket via the fiberoptic cable. The blanket is applied to the patient so as to maximize the patient contact with the blanket.

{1}------------------------------------------------

The second mode is transillumination. A fiberoptic cable is attached to the illuminator, and the visible light spectrum (white light) appears at the of this fiberoptic cable is used for facilitating vascular stick or injections; it is also used for finding pneumothoraces. Transilluminators have been used, and are being used, in NICUs and nurseries all over the world. Their intended use and user familiarity are well established.

Performance Data

Since treatment of neonatal hyperbilirubinemia with phototherapy is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied.

Assessment of Technological Characteristics

The technological characteristics of the BiliBlanket Plus High Output Phototherapy System are similar to those of the predicate devices and do not raise new safety or effectiveness issues.

Sterilization Information

The BiliBlanket Plus High output Phototherapy System is not intended to be sterilized. Cleaning and disinfecting instructions can be found in the Operation and Maintenance Manual.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 9 1999

Alberto F. Profumo, R.A.C. Director, Product Assurance Ohmeda Medical 9065 Guilford Road 21046-1801 Columbia, MD

Re : K993712 Ohmeda Medical-BiliBlanket Plus High Output Trade Name: Phototherapy System Regulatory Class: II Product Code: FMZ November 2, 1999 Dated: November 3, 1999 Received:

Dear Mr. Profumo:

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 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

{3}------------------------------------------------

Page 2 - Mr. Profumo

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known):

K9937/2

Device Name: BiliBlanket Plus High Output Phototherapy System

Indications For Use:

The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly knowas neonatal jaundice, during the newborn period in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
------------------------------------------	-----------------

Over- The Counter Use	_________________
(Optional Format 1-2-96)

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number	K993712
---------------	---------

Regulation Number and Section

§ 880.5400 Neonatal incubator.

(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).