(392 days)
Not Found
No
The description focuses on optical measurement and correlation with serum bilirubin, with no mention of AI or ML algorithms for data processing or interpretation. The core functionality is stated to be equivalent to the predicate device (JM-103), which is also described as a standard transcutaneous bilirubinometer.
No.
The device is a diagnostic tool that measures bilirubin levels to assist in monitoring, not to treat the condition itself.
No
The text explicitly states: "The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements." and "Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations." This indicates it's a screening/monitoring tool, not a diagnostic one.
No
The device description explicitly states it is a "portable, hand held, battery powered device that includes a docking station with a built in reading checker." This indicates it is a physical hardware device, not software only.
Based on the provided text, the Jaundice Meter (JM-105) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue. They are used to detect diseases, conditions, or infections.
- JM-105 Function: The JM-105 is described as a "non-invasive transcutaneous bilirubinometer." It measures the yellowness of subcutaneous tissue directly on the skin of newborn infants. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it "measures yellowness of subcutaneous tissue" and "provides a visual digital measurement that has been shown to correlate with serum bilirubin." It is used to assist clinicians in monitoring and is not a standalone diagnostic tool. It explicitly states that specific bilirubin levels should be confirmed by other methods, such as serum bilirubin (which is an in vitro test).
Therefore, because the JM-105 performs its measurement directly on the body and does not analyze a sample taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a non-invasive medical device used for monitoring.
N/A
Intended Use / Indications for Use
The Jaundice Meter (JM-105) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit pro-vides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements.
Newborn infants whose JM-105 Jaundice Meter test results are indicative of hy-perbilirybinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
The JM 105 is a prescription medical device
- The JM 105 is not intended for home use.
The JM 105 may only be used at the sternum measurement site for Physician's office applications.
Product codes (comma separated list FDA assigned to the subject device)
MOM, MQM
Device Description
The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The JM-105 is a portable, hand held, battery powered device that includes a docking station with a built in reading checker. The JM-105 batteries can be charged using a battery charger or an optional USB cable.
The basic functionality including measurement of the JM-105 is equivalent to the JM-103. The display of the JM-105 has been improved (larger screen, touchscreen) and data storage and transmission functionality was added. The measuring probe, hardware, and software used to process the measurements are identical and therefore use the same measuring principle. The JM-103 and JM-105 determines the yellowness of subcutaneous tissue by using two optical paths to measure the optical density difference at two wavelengths. The measuring principle is further described in the "Principles of Operations" section of the Instructions for Use.
In addition to the features offered with the JM-103, the JM-105 provides the following.
- Internal memory up to 100 patient files
- Data transfer via HL7
- Easily mark & ID babies that need special attention with patient flagging
- Cost-efficient screening
There are no sterile or single-use components or accessories for the JM-105.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue, sternum measurement site
Indicated Patient Age Range
newborn infants, infants less than 30 days old, infants up to 14 days of age, infants > 35 weeks gestation
Intended User / Care Setting
hospitals, clinics or doctor's offices under a physicians supervision / direction
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)
The submission includes the results of testing for the JM-105 to demonstrate compliance to the product requirements including electrical, mechanical, and software testing. Additionally, testing was performed to assess compliance to IEC60601-1 and IEC60601-1-2.
Clinical performance data for the JM-103 was provided in K042522 to determine the accuracy and precision of transcutaneous bilirubin (TcB) measurements in neonates.
Hospital Study Design: Patient selection criteria included infants less than 30 days old and weighing greater than 1000 grams. The studies primarily included NICU and newborn infants. The test was performed on infants determined by their physician to require a serum bilirubin test. Significant effort was made to ensure representation of all skin pigmentation for consistent results across Caucasian, African-American, East-Asian, Indian-Pakistani, and Hispanic infants.
Doctor's Office Study Design: Studies were performed at two doctors' office sites comparing JM-103 Total Calculated Bilirubin (TcB) to laboratory measured total serum bilirubin (TSB). The ages of infants in this study ranged from approximately 24 hours to 7-10 days, with a mean of 3 days (at site 1) and 5 days (at site 2). The test was performed on infants determined by their physician to require a serum bilirubin test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Clinical Data Standard Error of Estimate) ±1.5 mg/dL or ±25.5umol/L (>35 weeks gestation)
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
§ 862.1113 Bilirubin (total and unbound) in the neonate test system.
(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
DRAEGER MEDICAL SYSTEMS, INC. BRYAN OVERTON DIRECTOR, QA AND COMPLIANCE 3135 QUARRY RD TELFORD PA 18969
Re: K133175
Trade/Device Name: Jaundice Meter JM-105 Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: I, reserved Product Code: MOM Dated: September 26, 2014 Received: September 26, 2014
Dear Mr. Overton:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), 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/Resourcesfor You/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 yours.
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K133175
Device Name Jaundice Meter JM-105
Indications for Use (Describe)
The Jaundice Meter (JM-105) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit pro-vides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements.
Newborn infants whose JM-105 Jaundice Meter test results are indicative of hy-perbilirybinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
The JM 105 is a prescription medical device
- The JM 105 is not intended for home use.
The JM 105 may only be used at the sternum measurement site for Physician's office applications.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ☑ | ☐ |
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3
510(k) Summary
acc. to 807.92
| Submitter's Name and Address: | Draeger Medical Systems, Inc
3135 Quarry Road
Telford, PA 18969 USA |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Overton
Phone: 215.660.2135
Fax: 215.721.5424 |
| Date submission was prepared: | November 6, 2014 |
| Device Name: | Proprietary Name: Jaundice Meter JM-105
Common Name: Transcutaneous Bilirubinometer
Classification Name: Bilirubin (total and unbound) in the neo
nate test system
Regulation Number: 21 CFR 862.1113
Product Code: MQM |
| Class: | I, reserved |
Predicate Devices:
| 510(k) Number | Device Name |
|---|---|
| K042522 | Draeger JM-103 Jaundice Meter |
Intended Use/Indications for Use
The Jaundice Meter (JM-105) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements.
Newborn infants whose JM-105 Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.
The JM 105 is a prescription medical device The JM 105 is not intended for home use.
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510(k) Summarv JM-105
Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue. The word is the logo for the Dräger company.
The JM 105 may only be used at the sternum measurement site for Physician's office applications.
Further information on application
Newborn infants whose Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physicians for appropriate patient management. Specific neonatal patient bilirubin levels should be confirmed by other methods, such as serum bilirubin, before treatment determinations.
Limitations (Doctors Office Use)
Use only on infants up to 14 days of age.
For doctors' office application, use only the sternum location when taking measurements.
Please be aware, performance in doctors' offices may vary from performance in hospitals.
Device Description:
The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.
The JM-105 is a portable, hand held, battery powered device that includes a docking station with a built in reading checker. The JM-105 batteries can be charged using a battery charger or an optional USB cable.
The basic functionality including measurement of the JM-105 is equivalent to the JM-103. The display of the JM-105 has been improved (larger screen, touchscreen) and data storage and transmission functionality was added. The measuring probe, hardware, and software used to process the measurements are identical and therefore use the same measuring principle. The JM-103 and JM-105 determines the yellowness of subcutaneous tissue by using two optical paths to measure the optical density difference at two wavelengths. The measuring principle is further described in the "Principles of Operations" section of the Instructions for Use.
In addition to the features offered with the JM-103, the JM-105 provides the following.
- Internal memory up to 100 patient files
- Data transfer via HL7
- Easily mark & ID babies that need special attention with patient flagging
- Cost-efficient screening
There are no sterile or single-use components or accessories for the JM-105.
5
Image /page/5/Picture/0 description: The image shows the word "Dräger" in blue. The font is bold and sans-serif. The two dots above the "a" are also blue. The word is centered in the image.
JM-105 Comparison to JM-103 Predicate
| Draeger JM-105 | Draeger JM-103 | |
|---|---|---|
| Intended Use | The Jaundice Meter (JM-105) is | |
| a non-invasive transcutaneous | ||
| bilirubinometer. It measures | ||
| yellowness of subcutaneous | ||
| tissue in newborn infants. | Same | |
| Special condition for use | The Jaundice Meter is indicated | |
| for use in neonatal patients born |
35 weeks gestation who have
not undergone transfusion or
phototherapy treatment. | Same |
| Measuring Method | Determines the yellowness of
subcutaneous tissue by using
two optical paths to measure the
optical density difference at two
wavelengths | Same |
| Measuring range | 0.0 to 20.0 mg/dL or 0 to 340
umol/L | Same |
| Accuracy (Clinical Data
Standard Error of Esti-
mate) | ±1.5 mg/dL or ±25.5umol/L
(>35 weeks gestation) | Same |
| Light Source | Pulse Xenon Arc Lamp | Same |
| Sensors | Silicon photodiodes | Same |
| Power Source | 2.4V, Special Ni-MH battery | Same |
| Protection type & level | Internally powered instrument,
BF type | Same |
| Dimensions | 56mm(W)×168mm(H)×45mm(D) | 48mm(W)x154mm(H)x32mm (D) |
| Weight | 203g including Ni-MH battery) | 150g including Ni-MH battery) |
| Averaging function | Single, Avg. 1, 2, 3, 4 or 5 | Same |
| Data Storage and Trans-
mission | Yes | No |
Substantial Equivalence:
The JM-105 and the above referenced predicate device have the same intended use. These devices are used by health care professionals as a screening device used on newborn infants to detect hyperbilirubinemia.
The measurement principle used in JM-105 is equivalent to that of the JM-103, and has been proven to be effective in screening infants > 35 weeks gestation.
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Image /page/6/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The word is written in all capital letters except for the "ä", which has two dots above it. The font is sans-serif and the letters are closely spaced together. The background is white.
Summary of Nonclinical Testing
This submission includes the results of testing for the JM-105 to demonstrate compliance to the product requirements. This includes electrical, mechanical, and software testing.
Testing was also performed to assess compliance to the following recognized consensus standards:
- IEC60601-1, Medical Electrical Equipment, Part 1: General Requirements . for Safetv
- IEC60601-1-2, Medical Electrical Equipment, Part 1-2: General Require-. ments for Safety Collateral Standard: Electromagnetic Compatibility
The test reports and results are located in section 10 of the submission.
Clinical Performance
The clinical performance data is provided in the JM-103 510(k) premarket notification (see K042522). The objective of the studies were to determine the accuracy and precision of transcutaneous bilirubin (TcB) measurements in infants neonates.
Hospital Study Design
Selection criteria
The patient selection criteria used for the studies included infants less than 30 days old and weighing greater than 1000 grams. Although the selection criteria was established as "less than 30 days of age," the infants in the hospital studies were primarily NICU and newborn infants unless their medical condition required a longer duration of care. The test was performed on infants who were determined by their physician to require a serum bilirubin test.
Demographics of patient population
All patients meeting the above criteria were included in the study. There was significant effort to ensure sufficient representation of all skin pigmentation to verify that the JM-103 could be used across all populations with consistent results. The demographics of the patient population included Caucasian, African-American, East-Asian, Indian-Pakistani, and Hispanic infants.
Doctor's Office Study Design
Studies were performed at two doctors' office sites comparing JM-103 Total Calculated Bilirubin (TcB) to laboratory measured total serum bilirubin (TSB).
Selection criteria
The ages of the infants in the study ranged from approximately 24 hours to 7-10 days, with a mean of 3 days (at site 1) and 5 days (at site 2). The
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Image /page/7/Picture/1 description: The image shows the word "Dräger" in blue. The font is bold and sans-serif. The two dots above the "a" are also blue. The word is likely a logo for the Dräger company, which is a German company that makes medical and safety technology.
test was performed on infants who were determined by their physician to require a serum bilirubin test.
Conclusions
Based on the data and information presented in this submission, the JM-105 is substantially equivalent to the currently legally marketed to predicate device referenced above.