PAIN VISION, MODEL PS-2100

K072882 · Osachi Co., Ltd. · LLN · Jan 8, 2009 · Neurology

Device Facts

• Record ID: K072882
• Device Name: PAIN VISION, MODEL PS-2100
• Applicant: Osachi Co., Ltd.
• Product Code: LLN · Neurology
• Decision Date: Jan 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1200
• Device Class: Class 1

Intended 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.

Device Story

PS-2100 is a sensory nerve threshold measurement system. It applies gradually increasing electrical stimuli via disposable gel electrodes attached to a patient. The patient uses a hand switch to signal when they first perceive the stimulation; the device records this as the Current Perception Threshold (C.P.T.) value. Used by healthcare professionals in clinical settings for routine neurological exams or screening. Operates in standalone mode or connected to a PC for data administration. By quantifying sensory thresholds, the device assists clinicians in identifying neurological impairments and diagnosing peripheral neuropathy, potentially enabling earlier intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sensory nerve threshold measurement system. Electrical stimulation via disposable gel electrodes. Operates in standalone or PC-connected modes. Complies with ISO13485:2003, IEC60601-1:1988+A1+A2, IEC60601-1-1:2000, IEC60601-1-2:2004, IEC60601-2-40:1998, and ISO10993-1:2003.

Indications for Use

Indicated for quantitative detection of sensory neurological impairments and evaluation/diagnosis of peripheral neuropathy in individuals capable of communicating cutaneous sensation perception.

Regulatory Classification

Identification

A two-point discriminator is a device with points used for testing a patient's touch discrimination.

Predicate Devices

• NEUROMETER (K853608)

Submission Summary (Full Text)

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#### 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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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510(k) Notification - PS-2100

K072882

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.

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#### 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 |

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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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