Jiajian® Pointoselect Digital is a newly designed and easy to operate hand held stimulator. It is 9V battery powered device, with an LCD in the console. which can display the selected operation mode, intensity, frequency, pulse width, and battery level of the device, and so on. The device composes of a console, a hand held probe, a hand grip electrode, and lead wires. The hand probe can be used for treatment at individual sites. When using the hand probe, the patient must hold the hand grip electrode in order to electrically ground the device.

AI/ML Overview

The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it details a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, the Jiajian® Pointoselect Digital, focusing on its substantial equivalence to a predicate device (Pointer Excel) based on technical characteristics and compliance with safety and biocompatibility standards.

Therefore, many of the requested categories (sample size, data provenance, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable or cannot be extracted from this document, as they relate to clinical studies or performance evaluations that are not present.

However, I can extract the acceptance criteria related to technical specifications and safety standards compliance and the reported performance based on the substantial equivalence discussion and safety and effectiveness section.

Here's the information that can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are defined by the comparison to the predicate device and compliance with established safety/biocompatibility standards.

Feature	Acceptance Criteria (Predicate Device K060517 Performance)	Reported Device Performance (Jiajian® Pointoselect Digital)	Notes
Intended Use	Symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.	Symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.	Met: Identical intended use.
Power Source	DC 9V battery, Type 6F22	9 Volt battery type 6F22 (Carbon-zinc), or 9 Volt battery type 6LR61 (Alkaline)	Met: Similar DC battery power source.
Waveform	Biphasic	Biphasic	Met: Identical waveform.
Shape	Asymmetric biphasic square wave	Asymmetric biphasic square wave	Met: Identical wave shape.
Net Charge	0μC@500Ω	0μC @500Ω, + and - pulses cancel	Met: Identical net charge.
Frequency Range	1-16Hz	2~18Hz	Met: Similar frequency range, subject to "differences would not raise new safety concerns."
Maximum Output Voltage	11V ±15% @500Ω	6.6V ±15% @500Ω	Different: Lower for new device. Document asserts "differences would not raise new safety concerns."
Maximum Output Current	22mA ±15% @500Ω	13.2mA ±15% @500Ω	Different: Lower for new device. Document asserts "differences would not raise new safety concerns."
Pulse Duration	220μS	60-120μS	Different: Shorter for new device. Document asserts "differences would not raise new safety concerns."
Maximum Phase Charge	4.8μC@500Ω	2.4μC@500Ω	Different: Lower for new device. Document asserts "differences would not raise new safety concerns."
Maximum Current Density (r.m.s.)	10.35mA/cm²@500Ω	12.08mA/cm²@500Ω	Similar: Slightly higher for new device. Document states "similar maximum output current density."
Safety Standard Compliance	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (for predicate)	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 (for new device)	Met: New device was tested and found to meet these safety standards.
Biocompatibility Standards	ISO 10993-5, ISO 10993-10 (for predicate)	ISO 10993-5, ISO 10993-10 (for new device, specifically pointer probe)	Met: New device's pointer probe was tested and found to comply with these biocompatibility standards. Lead wires also tested to IEC 60601-1.
Battery Life Impact	Not explicitly stated	Stimulus parameters not significantly affected (less than ±10%) with reduced battery level.	Met: Specific testing for performance under reduced battery conditions.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The document describes a comparison of technical specifications and compliance with standards, not a clinical trial or performance study involving patient data.
Data Provenance: Not applicable, as no human subject data (retrospective or prospective) is discussed. The device is manufactured in Wuxi, Jiangsu, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of "ground truth" established by experts in the context of clinical performance or diagnostic accuracy. The assessment is based on engineering specifications and adherence to standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is described as there is no clinical test set requiring it.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (TENS) for pain relief, not an algorithm or AI system.

7. The type of ground truth used

Not applicable. The document assesses the device against technical specifications and safety/biocompatibility standards, not against a "ground truth" derived from clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2013

Wuxi Jiaiian Medical Instrument Co., Ltd. c/o Ms. Doris Dong, Manager Shanghai CV Technology Co., Ltd. Room 1706, No. 128 Songle Rd., Songiiang Area Shanghai 201600 China

Re: K123958

Trade/Device Name: Jiajian Pointoselect Digital Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: September 17, 2013 Received: September 25, 2013

Dear Ms. Dong:

This letter corrects our substantially equivalent letter of October 28, 2013.

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.

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Page 2 - Ms. Doris Dong

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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, Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

510(k) Number (if known): K123958

Device Name: Jiajian® Pointoselect Digital

Indications for Use:

The Jiajian® Pointoselect Digital is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Prescription Use _ (Part 2) CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi. Jiangsu, China 214116

K123958

Section 5 510(k) Summary [As required by 21 CFR 807.92]

1. Submission Information:
510(k) Number:
Date:
Type of 510(k) Submission:
Basis for 510(k) Submission:
Submitter/Manufacturer:

e of 510(k) Submission:
sis for 510(k) Submission:
omitter/Manufacturer:

Contactor:

OCT 2 8 2013 March 13th, 2013 Traditional New device Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116 Doris Dong, Consultant Shanghai CV Technology Co., Ltd. Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, China 201600 E-mail: doris_d@126.com / Url: www.ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-37824346

Device Description:

Proprietary Name: Jiajian® Pointoselect Digital Common Name: Transcutaneous electrical nerve stimulator Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890 Product Code: GZI Device Class: ll Review Panel: Neurology Indications for use: Jiajian® Pointoselect Digital is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain. Device Description:

The device composes of a console, a hand held probe, a hand grip electrode, and lead wires.

The hand probe can be used for treatment at individual sites. When using the hand probe, the patient must hold the hand grip electrode in order to electrically ground the device.

Standards:

IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2

ISO 10993-5, ISO 10993-10;

3. Predicate Device Identification

510k Number:	K060517
Product Code:	GZJ
Device Name:	Pointer Excel
Manufacturer:	LHASA OMS, INC.

4. Substantial Equivalence:

Detailed comparison data is included in the section of "Substantial Equivalence Discussion" of this 510(k) submission.

A. Basic technological characteristics, New device VS. Predicate device:

	REAMPIEFS	9.000 b.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Canada Banks100 - 100 - 20 - 40 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	510/b) Nimb	1°199000-----------------------------------	K060517

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Wuxi Jiajian Medical Instrument Co., Ltd ..... .. .

Image /page/4/Picture/1 description: The image shows a logo with the text "JIA JIAN" in bold, black letters. A checkmark symbol is placed above the letters "IA", and a circled "R" registration mark is located to the right of the word "JIAN". Below the text, there are some Chinese characters.

		Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116
2.	Marketing clearance date:		Jun 19th, 2006
3.	Device Name	Jiajian Pointoselect Digital	Pointer Excel
4.	Manufacturer	Wuxi Jiajian Medical Instrument Co., Ltd	LIIASA OMS, INC.
5.	Accessories for stimulation	I pcs. of hand probe for stimulation with	I pcs. of hand probe for stimulation;
	mode	lead wire;1 pcs. of hand electrode with lead wire	I pcs. of hand electrode with lead wire
6.	Intended use	Jiajian® Pointoselect Digital is intendedfor use in the symptomatic relief ofchronic intractable pain, postoperativepain, and acute pain.	Pointer Excel is intended for use in thesymptomatic relief of chronic intractablepain, postoperative pain, and acute pain.
7.	Power Source(s)	9 Volt battery type 6F22 (Carbon-zinc), or9 Volt battery type 6LR61 (Alkaline)	DC 9V battery, Type 6F22
	- Method of Line CurrentIsolation	N/A for DC current	N/A for DC current
	- Patient Leakage Current	-	-
	- Normal Condition	20μA	Not Stated in the manual
	- Single Fault Condition	N/A	Not Stated in the manual
8.	Number of Output Mode:	1	1
9.	Number of Output channels:	1	1
10:	Compliance with VoluntaryStandards?	ISO 10993-5, ISO 10993-10:IEC 60601-1, IEC 60601-2-10, IEC60601-1-2	ISO 10993-5, ISO 10993-10:IEC 60601-1, IEC 60601-2-10, IEC60601-1-2
11.	Waveform	Biphasic	Biphasic
12.	Shape	Asymmetric biphasic square wave	Asymmetric biphasic square wave
13.	Maximum Output Voltage	$6.6V ±15% @500Ω$	$11V±15% @500Ω$
14.	Maximum Output Current	$13.2mA ±15% @500Ω$	$22mA ±15% @500Ω$
15.	Pulse Duration	60-120μS	220μS
16.	Frequency	2~18Hz	1-16Hz
17.	Net Charge	0μC @500Ω, + and - pulses cancel	0μC@500Ω
18.	Maximum Phase Charge	2.4μC@500Ω	4.8μC@500Ω
19.	Maximum Current Density	12.08mA/cm²@500Ω	10.35mA/cm²@500Ω
	(r.m.s.)

B. Substantial Equivalence Discussion

Similarities between New deviceand Predicate Device:	Intended use, DC power source, biphasic square waveform, Net charge, frequencyrange, maximum current density, maximum power density, adjustable frequencies andintensity, standards
Differences between New deviceand Predicate Device:	Weight, dimensions: Maximum output voltage, Maximum output current, Output pulseduration, Maximum phase charge
Conclusion:	The new device has same intended use, biphasic square waveform, complied standards,adjustable output intensity and frequency, and similar maximum output current densityand power density.Though there are differences between the new devices and the predicate devices, such asoutput intensity values and pulse width, the differences would not raise new safetyconcerns.To sum up, the new device Jiajian Pointoselect Digital is substantially equivalent toPredicate devices of Pointer excel (K060517).

Similarities between New deviceand Predicate Device:

Intended use, DC power source, biphasic square waveform, Net charge, frequencyrange, maximum current density, maximum power density, adjustable frequencies andintensity, standards

Differences between New deviceand Predicate Device:

Weight, dimensions: Maximum output voltage, Maximum output current, Output pulseduration, Maximum phase charge

Conclusion:

The new device has same intended use, biphasic square waveform, complied standards,adjustable output intensity and frequency, and similar maximum output current densityand power density.Though there are differences between the new devices and the predicate devices, such asoutput intensity values and pulse width, the differences would not raise new safetyconcerns.To sum up, the new device Jiajian Pointoselect Digital is substantially equivalent toPredicate devices of Pointer excel (K060517).

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Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu. China 214116

5. Safety and Effectiveness of the device

Jiajian® Pointoselect Digital was tested and found to meet the safety standards of:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;
IEC 60601-2-10 Edition 2.0 2012-06, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators; and
IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests

The pointer probe was tested and found to comply with the biocompatibility standards of:

· ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Viro cytotoxicity, and * ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and

delayed-type hypersensitivity

The output lead wires used for Jiajian® Pointoselect Digital were tested and found to comply with the safety standards of:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment I, 1991-11, Amendment 2, 1995

The device was also tested basis on reduced battery level, and was found that the stimulus parameters were not significantly affected (less than ±10%).

The conclusion drawn from the testing is that the device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).