(75 days)
Not Found
No
The summary describes a device that measures temperature and vibration sensitivity, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "screening" device intended to "determine" or "observe" changes in sensation and "diagnose" conditions, rather than to treat or alleviate them.
Yes
The device is described as providing "objective medical screening for peripheral neuropathy" and determining the "patient's ability to discriminate temperature differences" and "vibration sensitivity," which are diagnostic functions. It screens patients to "observe any changes of sensation over a period of time" and provides "an objective method for screening patient's feet for neuropathy," all of which fall under diagnosing or aiding in diagnosis.
No
The device description explicitly mentions a "cradle which provides a docking location for the handle" and describes the device as being "ergonomically comfortable in the practitioner's hand," indicating a physical hardware component beyond just software. It also mentions safety features related to temperature and electrical pathways, further suggesting a hardware device.
Based on the provided information, the Dynamic Neuroscreening Device (DND) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- DND's Function: The DND directly interacts with the patient's body (feet) to assess their ability to feel temperature differences and vibrations. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "objective medical screening for peripheral neuropathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity." This is a direct physiological assessment, not an in vitro analysis of a specimen.
Therefore, the DND falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dyaamic Newssreaing Device (DND) is intended to provide objective medical screening for peripheral newopathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
Product codes
LLN, LQW
Device Description
The Dynamic Neuroscreening Device (DND) is intended to screen patients and allow the practitioner to observe uny changes of sensation over a period of time. The device will be available with a cradle which provides a docking location for the handle. The DND device provides medical practitioners with an objective method for screening patient's feet for neuropathy. The device uses two methods for long term screening with the objective of determining loss of sensation in the patient's foot: vibration sensitivity and temperature discrimination screening. The primary patient population is for those that arc at risk or have been diagnosed with diabetes.
The DND is designed to be ergonomically comfortable in the practitioner's hand and simple to use. In addition safety features are installed to provent the device from becoming excessively hot or cold to ensure untient safety. No electrical pathways are going to the patient and the power supply is UL upproved to the medical device standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioners
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
Nonclinical testing consisted of vibrational and temperature verification in addition to electrical safety testing.
No clinical testing was performed in association with this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1200 Two-point discriminator.
(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a caduceus, a symbol associated with medicine and healthcare. The text on the right is the name of the organization, with "FDA" in a bold, black square.
MAR 1 3 2019
Prosenex William McLain President and Principal Consultant 342 E. Main St. Suite 207 Leola, Pennsylvania 17540
Re: K141208
Trade/Device Name: Dynamic Neuroscreening Device Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN, LQW Dated: May 5, 2014 Received: May 9, 2014
Dear William McLain:
This letter corrects our substantially equivalent letter of July 23, 2014.
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.
1
K141208 - William McLain
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
KJ41208
Device Name
Dynamic Neuroscreening Device
Indications for Use (Describe)
The Dyaamic Newssreaing Device (DND) is intended to provide objective medical screening for peripheral newopathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpert D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Please Do Not WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Felipe Date: 2014.07.23 Aquel -S 21:16:49 -04'00'
This section applies only to requirements of the Paperwark Reduction Act of 1995.
'Do Not SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 70 hours par response, including the time to review instructions, search existing data sources, nather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStefficalda.hhs.gov
"An agency may not conduct or spansor, and a person is not required to respond to, a collection of information unloss it displays a currently valld OMB number."
FORM FDA 3881 (1/14)
3
JUL 2 3 2014 K141208
Section 5
510(K) Summary
Submission Correspondent and Owner 5.1
Submission Correspondent
Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Phone: (717) 656-9656 Fax: (717) 656-3434 Email: bill.mclain@keystoncregulatory.com
Sponsor (Owner)
Mr. James Bernhard Vice President Prosenex, LLC 33 Constitution Drive Hudson, NH 03051 Phone: 603-546-0457 Fax: 603-595-8277 cmail: jbernhard@prosenex.com
5.2 Date Summary Prepared
May 2, 2014
4
SECTION 5. 510(K) SUMMARY
5.3 Device Trade Name
Dynamic Neuroscreening Device
5.4 Device common name
Temperature Discrimination Device and Tuning Fork
5.5 Device classification name
Temperature Discrimination Test, LQW, Unclassified
5.6 Legally Marketed Device To Which The Device Is Substantially Equivalent
The Dynamic Neuroscreening Device is substantially equivalent to:
- · The Sensortek NTE-2 Thermal Sensory Tester cleared under K864345.
- · The Somedic Vibrameter cleared under K843486.
5.7 Description Of The Device
The Dynamic Neuroscreening Device (DND) is intended to screen patients and allow the practitioner to observe uny changes of sensation over a period of time. The device will be available with a cradle which provides a docking location for the handle. The DND device provides medical practitioners with an objective method for screening patient's feet for neuropathy. The device uses two methods for long term screening with the objective of determining loss of sensation in the patient's foot: vibration sensitivity and temperature discrimination screening. The primary patient population is for those that arc at risk or have been diagnosed with diabetes.
The DND is designed to be ergonomically comfortable in the practitioner's hand and simple to use. In addition safety features are installed to provent the device from becoming excessively hot or cold to ensure untient safety. No electrical pathways are going to the patient and the power supply is UL upproved to the medical device standard.
5
SECTION 5. 510(K) SUMMARY
Intended Use 5.8
The Dynamic Neuroscreening Device (DND) is intended to provide objective medical screening for peripheral neuropathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
3
5.9 Technological Characteristics
The Dynamic Neuroscrooning Device has identical technical charactoristics as the predicate devices. Table 3.1 describes the basic features of the DND as compared to the Sensortek NTE-2 Thermal Sensory Tester cleared under K864345 and the Somedic Vibrameter cleared under K843486. Comparisons related to temperature and vibration are presented.
6
| Table 5.1: Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Feature or Specifica- | ||||
| tion | Sensortek NTE-2 | |||
| Tester (K864345) | Thermal Sensory | Dynamic Neuroscreening Device (Pro- | ||
| posed Device) | ||||
| Minimum Temperature | ||||
| (deg C) | 0 | 15 | ||
| Maximum Temperature | ||||
| (deg C) | 50 | 40 | ||
| Control Accuracy (deg | ||||
| C) | 0.1 | 0.5 | ||
| Temperature Gradient | ||||
| Steps (deg C) | 5, 1, and 0.5 | Fixed at 2 |
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| Feature or Specifica-
tion | | Somedic Vibrameter (K843486) | Dynamic Neuroscreening Device (Pro-
posed Device) |
|------------------------------------------------------------|-----------|------------------------------|------------------------------------------------------|
| Vibration
(Hz) | Frequency | 100-120 | 175 |
| Vibration
Range (microns) | Amplitude | 0 to 40 and 0 to 400 | 4.5 to 23 |
| Vibration Amplitude Set
Point Resolution (Mi-
crons) | | 5% | 20% |
and the control of the country
- September 19. 1. 1.
1999 - 1999 - 1999
Carlos Career Comments of Children
7
SECTION 5. 510(K) SUMMARY
. .
Non-Clinical Testing 5.10
Nonclinical testing consisted of vibrational and temperature verification in addition to electrical safety testing.
5.11 Biocompatibilty
Due to the materials of construction, biocompatibility testing was not performed.
Clinical Testing 5.12
No clinical testing was performed in association with this submission.
5.13 Conclusions
The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.