(457 days)
Not Found
No
The description focuses on electrical stimulation and threshold measurement, with no mention of AI/ML terms or functionalities.
No.
The device is used for diagnosis and evaluation of sensory neurological impairments, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy." This directly indicates its role as a diagnostic device.
No
The device description explicitly mentions hardware components such as electrodes, a hand switch, and the device itself which applies electrical stimulus. It also describes a "Standalone mode" where the device itself is used for measurements, indicating it is not solely software.
Based on the provided information, the PS-2100 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- PS-2100 Function: The PS-2100 directly interacts with the patient's body by applying electrical stimulation to measure their sensory perception threshold. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as being used to detect sensory neurological impairments in individuals by measuring their perception of cutaneous sensation. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the PS-2100 falls under the category of a medical device used for physiological measurement and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-21.00's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
Product codes
LLN
Device Description
The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test.
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
any individual capable of communicating their perception of cutaneous sensation.
Intended User / Care Setting
healthcare professionals
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
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAY : 1 2017
Mr. James R. Greenwood. Ph.D., M.P.H Chairman, Regulatory Advisor Osachi Co., Ltd. c/o International Medical Device Partners. Inc. 3027 E. Sunset Rd., Suite 105 Las Vegas, NV 89120
Re: K072882
Trade/Device Name: PS-2100 Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: October 10, 2008 Received: November 7, 2008
Dear Dr. Greenwood:
This letter corrects our substantially equivalent letter of January 8, 2009.
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. Iisting 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
1
Page 2 - Dr. James R. Greenwood
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.
If you desire specific advice for your device on our labeling regulation (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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
for
Sincerely yours, Michael J
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
510(k) Notification - PS-2100
JAN - 8 2009
C. 510(K) summary
1. General Information
- Submitter's Name Address Telephone Contact Person .
: OSACHI Co., Ltd. : 9-11, Osachikohagi 2-chome, Okaya-shi, Nagano, Japan : 81-266-280866 : Dr. James R. Greenwood Ph. D., M.P.H. Registration Number : 8043882
2. Device
| Name | : PS-2100 |
|---|---|
| Trade Name | : PS-2100 |
| Common Name | : Sensory Nerve Threshold Measurement System |
| Classification Name | : device, vibration threshold measurement |
| Product Code | : LLN |
| Class | : II |
3. Identification of Legally Marketed Devices
| Name | : NEUROMETER |
|---|---|
| K Number | : K853608 |
4. Product Overview
The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test. For detailed information refer to Device Description.
3
510(k) Notification - PS-2100
Image /page/3/Figure/1 description: This image is a graph that shows the degree of perceived sensation over time. The x-axis is labeled "Time" and the y-axis is labeled "Degree of Perceived Sensation". There is a line that represents the minimum perception current, and another line that represents the stimulating current gradually increased. The point where the two lines intersect is labeled "CPT" and the sensation experienced by stimulating current.
5. Indication for use
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-21.00's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
6. Standard compliance list
| Application Standard | ISO13485:2003 | IEC60601-1-1:2000 |
|---|---|---|
| IEC60601-1:1988+A1+A2 | IEC60601-1-2:2004 | |
| IEC60601-2-40:1998 | ISO10993-1:2003 |
11
4
Image /page/4/Picture/0 description: The image shows a simple freehand drawing with a few distinct elements. A long, slightly curved line extends vertically, positioned towards the left side of the frame. To the right of this line, there's a rough sketch of a quadrilateral, resembling a rectangle or parallelogram, with dashed lines indicating some of its edges, suggesting it might be a 3D representation or an incomplete shape.
Applicant: OSACHI CO., LTD.
510(k) Number : K072882
Device Name: PS-2100
Indications for Use:
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
123,533
Over-the-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millican
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
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