(6 days)
Not Found
No
The summary describes a phototherapy device that provides therapeutic light and mentions compliance with electrical safety standards, but there is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as treating hyperbilirubinemia through phototherapy and is called a "medical device that provides therapeutic light."
No
The device is described as a treatment device for hyperbilirubinemia, providing therapeutic light, and is not mentioned to diagnose any condition.
No
The device description clearly states it is a "Phototherapy System" that provides therapeutic light through a "fiberoptic cable bundle and panel" and includes a "Phototherapy Illuminator" that operates on electrical voltages. These are hardware components, not software.
Based on the provided information, the Wallaby 3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to treat hyperbilirubinemia through phototherapy. IVD devices are used to diagnose or monitor conditions by examining samples from the body (like blood, urine, etc.).
- Device Description: The device provides therapeutic light. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens.
The Wallaby 3 is a therapeutic medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Wallaby 3 is intended to treat hyperbilirubinemia through phototherapy in a home or hospital environment. Some conditions which may require treatment include (but not exclusive to) are:
- Prematurity .
- . Liver Dysfunction
- ABO Incompatibility ●
- Diabetes in Mother ●
- Certain drugs .
Product codes (comma separated list FDA assigned to the subject device)
LBI
Device Description
The Wallaby 3 Phototherapy System is a medical device that provides therapeutic light through a fiberoptic cable bundle and panel for the treatment of neonatal jaundice (hyperbilirubinemia). The Wallaby 3 Phototherapy Illuminator, which is a replacement product for the Wallaby II, will work with existing Wallaby phototherapy panels. The Wallaby 3 illuminator operates on both domestic and international voltages (120VAC/230VAC, 50/60 Hz).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal
Intended User / Care Setting
Home or hospital environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The Wallaby 3 Phototherapy Illuminator has been tested and complies with the following standards:
- CSA-22.2 No. 601-1M90
- UL 2601-1
- EN60601-1
- EN60601-2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).
0
MAY 17 .
K99/627
510(k) SUMMARY
(As required by 21 CFR 807.93)
A 510(K) Summary for the Wallaby 3 Phototherapy System ™ is listed below. A separate copy of the summary on Respironics letterhead is also included in Appendix A2 at the end of this section.
| Establishment
| Registration Number: | 1040777 |
|---|---|
| Submitter: | Betsy Cortelloni |
| Respironics Georgia, Inc. | |
| 1255 Kennestone Circle | |
| Marietta, GA 30066 | |
| Phone: 770-429-2894 | |
| Fax: 770-499-1418 | |
| Date Prepared: | 07-May-1999 |
| Name of Contact: | Betsy Cortelloni, Regulatory Affairs Manager |
| Device Name: | Wallaby 3 Phototherapy System™ |
| Device Model Number: | 3600 |
| Classification Name: | Neonatal Phototherapy, 21 CFR 880.5700 |
| Device Classification: | LBI |
| Predicate Devices: | Fiberoptic Medical Products, Inc., Wallaby II cleared |
| under K883779 (11/14/1988) | |
| Device Description: | The Wallaby 3 Phototherapy System is a medical device |
| that provides therapeutic light through a fiberoptic cable | |
| bundle and panel for the treatment of neonatal jaundice | |
| (hyperbilirubinemia). The Wallaby 3 Phototherapy | |
| Illuminator, which is a replacement product for the | |
| Wallaby II, will work with existing Wallaby phototherapy | |
| panels. The Wallaby 3 illuminator operates on both | |
| domestic and international voltages (120VAC/230VAC, | |
| 50/60 Hz). |
Image /page/0/Picture/6 description: The image shows the logo for Respironics. The logo consists of a triangle with a stylized figure inside, and the word "RESPIRONICS" written below. The figure inside the triangle appears to be a person with arms outstretched, and there are two dots, one above the triangle and one below the figure.
MARIETTA, GA. 30066
FILENAME: WALLABY.DOC
েটার প্রেরণ করে পারে।
এরপর প্রথম বিশ্বকাপের প্রতিষ্ঠান করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে 5
1
(510(k) summary con't)
Intended Use:
The Wallaby 3 is intended to treat hyperbilirubinemia through phototherapy in a home or hospital environment. Some conditions which may require treatment include (but not exclusive to) are:
- Prematurity .
- . Liver Dysfunction
- ABO Incompatibility ●
- Diabetes in Mother ●
- Certain drugs .
Comparison of Technological Characteristics:
The Wallaby 3 phototherapy illuminator is an improvement over its predecessor, Wallaby II. Both devices provide therapeutic light delivered from an MR16 type, 150 watt, tungsten-halogen bulb through fiberoptic cable. The existing fiberoptic cable and panel (available in two sizes) has not changed as a result of the new device.
The light intensity settings will be identical to the Wallaby II illuminator. The device will provide for two user selectable intensity levels. The two selectable levels shall be 25 µW/cm²/nm and 35 µW/cm²/nm for the smaller phototherapy panel (Model EG2000N) and 10 uW/cm2/nm and 15 uW/cm2/nm for the larger phototherapy panel (Model EG2000). The selection method shall be discrete and not continuously variable. The selector switch label has been revised from "Irradiance Level" to "Light Level" in order to clarify the function to the user.
Both devices have an optical filter to block any UV or near-IR radiation outside the 400-550 nm range that is emitted by the light source to avoid damaging the eyes and the skin.
Both devices have a redundant lamp system to ensure that the patient receives therapy with minimum interruption. The Wallaby II requires that the user push
Image /page/1/Picture/13 description: The image shows the logo for Respironics. The logo features a stylized human figure inside of a triangle. Below the triangle is the word "RESPIRONICS" in a bold, sans-serif font.
MARIETTA, GA. 30066
FILENAME: WALLABY.DOC
Image /page/1/Picture/16 description: The image contains a left parenthesis, a right parenthesis, and the number 6. The parentheses are next to each other, and the number 6 is to the right of the parentheses. The number 6 is bolded and slightly larger than the parentheses. The image is black and white.
2
| (510(k) summary con't) | |
|---|---|
| a manual button to move the back-up lamp into position once the primary lamp has failed. However, the Wallaby 3 has an automatic lamp redundancy system. This system automatically senses a lamp failure and moves the new lamp into position immediately. No action is required by the user to initiate this action. | |
| Both devices have a safety feature to prevent the user from looking directly at the light source when the panel is detached. None of our competitor's illuminators have this feature. | |
| Non-Clinical Testing: | The Wallaby 3 Phototherapy Illuminator has been tested and complies with the following standards: |
| CSA-22.2 No. 601-1M90UL 2601-1EN60601-1EN60601-2 | |
| Conclusion: | The Wallaby 3 Phototherapy System has the same intended use and functionality as the predicate Wallaby II. The data supports that Wallaby 3 is substantially |
equivalent to the Wallaby II.
Image /page/2/Picture/1 description: The image shows the logo for Respironics. The logo consists of a triangle with a stylized figure inside, and the word "RESPIRONICS" written below. The figure inside the triangle appears to be a person with a circle in the center of their chest.
MARIETTA, GA. 30066
FILENAME: WALLABY.DOC
C.O. 7
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an abstract human figure with three lines extending from the head, resembling wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 1939
Ms. Betsy Cortelloni Regulatory Affairs Manager Respironics® Georgia, Incorporated 1255 Kennestone Circle Marietta, Georgia 30066-6029
Re : K991627 Wallaby 3 Phototherapy System™, Model 3600 Trade Name: Requlatory Class: II Product Code: LBI Dated: May 10, 1999 Received: May 11, 1999
Dear Ms. Cortelloni:
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 aqainst 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. A 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 regulatory 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 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.
4
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in four and equivalence of your device to a legally rinding or babboan device results in a classification for your markets production of mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 ene office or compliaed, "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
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Center of Devices and Radiological Health
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Wallaby 3 is intended to treat hyperbilirubinemia through The Wallaby on a home or hospital environment.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cascardi
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K991627
PRESCRIPTION Denied
499