Bi-polar/multi-polar disposable concentric needles for recording muscle activity. The needles consist of a stainless steel hypodermic outer shell with a centered platinum/iridium inner recording core with a trocar sharpencd tip. An electrically insulated molded handle incorporates the contact points allowing electrical continuity through the connecting cable, which is sold separately.

AI/ML Overview

The Rochester Electro-Medical, Inc. Ultra Sharp Concentric Needles are diagnostic electromyograph needle electrodes. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Non-clinical Testing" section of the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Characteristic	Reported Device Performance
Core Centering & Size	Verified through microscopic visual examination.
Microscopic Visual Examination	Conducted to assess overall quality.
Sharpening	Microscopic visual examination with special attention to bevel convergence, burrs, and point. Also includes a foam test.
Electrical Continuity of all poles	Verified using an audible ohmmeter.
Electrical Isolation of all poles	Verified using an audible ohmmeter.
Needle hypodermic shell examination	Assessed for straightness and stated length.
Handle Mold Design	Visual and audible ohmmeter for electrical aspects.
Connector Interface	Visual and audible ohmmeter for electrical aspects.
Sterility	Achieved through Gamma Irradiation.
Biocompatibility	Materials (Stainless Steel & Platinum) are biocompatible.
Mechanical Safety	Packaged needle covered with a needle cover.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a separate "test set" sample size in the traditional sense for a clinical study. The device performance was evaluated through a series of internal "Non-clinical Testing" procedures, which include:

Process Control: Verification of manufacturing processes.
Process Verification: Done according to established control processes.
Design Verification: Performed using samples from the first production run, with methods identical to the Process Approval phase.

The "samples from the first production run" serve as the test set for design verification. The exact number of samples tested at each stage (Process Control, Process Verification, Design Verification) is not specified.

Data Provenance: The data appears to be retrospective and internal, derived from the manufacturer's own quality control and design verification processes conducted in the U.S. (Lutz, FL).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of external experts or a formal ground truth establishment process involving experts for the "Non-clinical Testing." The assessments were primarily based on internal quality control and manufacturing process verification, likely performed by manufacturing and quality control personnel. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described. The "Non-clinical Testing" relies on direct measurements, visual inspections, and functional tests (like ohmmeter readings) against predefined specifications. Discrepancies would likely be addressed through internal quality control protocols.

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. The submission focuses on the safety and effectiveness of the device itself through non-clinical bench testing, not on the improvement of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is a physical medical instrument (a needle electrode), not an algorithm or an AI-powered system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance described relates to the physical and electrical characteristics of the needle.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing appears to be based on:

Engineering Specifications/Design Parameters: For characteristics like core centering, size, length, and straightness.
Established Quality Control Standards: For visual examinations (burrs, bevel convergence, point) and functional tests (electrical continuity, isolation).
Industry Standards: Compliance with various ISO and AAMI/ANSI standards (e.g., ISO 13485, ISO 14971, ISO 10993-1, ISO 9626, ISO 7864).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device, not an AI/ML algorithm. The document describes manufacturing processes and design verification, not algorithm development.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set mentioned in the context of this device.

Summary

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KOROGIY

Image /page/0/Picture/1 description: The image is a circular emblem with the word "ROCHESTER" at the top. A stylized image of a pencil is in the center of the emblem. The phrase "Education for the Deaf Program" is at the bottom of the emblem. The emblem is black and white.

510(k) Summary

JUL 1 5 2008

Contact Details

Applicant Name: Rochester Electro-Medical, Inc.

4212 Cypress Gulch Dr. Lutz, FL 33559 U.S.A. 1-813-963-2933 1-813-960-4563 (FAX)

Charles C. Berkins, C.E.O. cberkins@rochesterelectromed.com

Date Prepared: July 3, 2008

Device Name

Trade Name: Ultra Sharp Concentric Needles

Common Name: EMG Needles, Concentric Needles, Bi-polar Needles

Classification Name: Electrode, needle, diagnostic, electromyograph; Diagnostic electromyography needle electrode; IKT

	Legally Marketed Predicate Device(s)
1

510(k) Number	Product Code	Trade Name	Manufacturer
K895460	IKT	CONCENTRICELECTRODE TYPE#13R01, 13R02	DANTECELECTRONICS, INC.
931966	IKT	DANTEC DISPOSABLECONCENTRIC NEEDLE	DANTEC MEDICAL, INC.
K924521	IKT	DISPOSABLECONCENTRIC NEEDLEELECTRODE	CHALGRENENTERPRISES, INC.
K896370	GXZ	DISP. CONCENTRICNEEDLE ELECTRODE(DCP-30, DCP-45	CHALGRENENTERPRISES, INC.
K933795	GXZ	CONCENTRIC EMGNEEDLE ELECTRODE	CADWELLLABORATORIES, INC.
K973529	IKT	NEUROLINE,DISPOSABLECONCENTRIC NEEDLEELECTRODE	MEDICOTEST A/S.
K960591	IKT	RE-USABLE BIPOLARCONCENTRICNEEDLE(237-XXX-24,23	CHALGRENENTERPRISES, INC.

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Device Description

Intended Use/Indications for use

Recording muscle activity for Electromyography (EMG) applications. For Single Patient Use only. Patient population: Adults.

Characteristic	Predicate Devices	Rochester Device
Indications for Use	Recording muscle activity forElectromyography (EMG)applications. For Single PatientUse only.	Recording muscle activity forElectromyography (EMG)applications. For Single PatientUse only.
Target Population	Adults	Adults
Design	Outer Hypodermic shell withinsulated inner recording core.Recording connections through amolded handle to a detachableconnecting cable.	Outer Hypodermic shell withinsulated inner recording core.Recording connections through amolded handle to a detachableconnecting cable.
Materials	Stainless Steel cannula, platinumOr silver core, Molded plastic handle	Stainless Steel cannula, platinumcore, Molded plastic handle
Performance	Unknown	Testing data: Core Centering & Size;Microscopic visual examination;Sharpening; Microscopic visualexamination with specialattention to bevel convergence, burrsand point; Electrical continuity of allpoles; Electrical isolation of all poles;Needle hypodermic shell examined forstraightness and stated length.
Sterility	Gamma Irradiation, E-Beam	Gamma Irradiation
Biocompatibility	Stainless Steel, Platinum & Silver	Stainless Steel & Platinum
Mechanical Safety	Packaged needle covered with aneedle cover.	Packaged needle covered with aneedle cover.
Chemical Safety	Not Applicable	Not Applicable
Anatomical Sites	Muscles and associated Nerves	Muscles and associated Nerves
Human Factors	Must be used by a trained, certifiedphysician or by order of a physician	Must be used by a trained, certifiedphysician or by order of a physician
Energy Used/Delivered	Not Applicable	Not Applicable
Compatibility with Other Devices	Compatibility is achieved through theconnecting cable to EMG machines orsimilar physiological recording devices.	Compatibility is achieved through theconnecting cable to EMG machines orsimilar physiological recording devices.
Where Used	Physician's office or Hospitals.	Physician's office or Hospitals.
Risk Analysis	Unknown	Risk Management completed 1-30-08 as part of the Design ControlProcess
Design Control	Unknown	Design Control Completed 1-30-08
Electrical Safety	Unknown	Controlled & accounted for withRisk Management.

Substantial Equivalence Comparison

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Design Control	Unknown	Design Control Completed 1-30-08
Electrical Safety	Unknown	Controlled & accounted for withRisk Management.
Options Offered	25 mm., 30 ga.30 mm., 28 ga.38 mm., 26 ga.75 mm., 23 ga.	25 mm., 26 ga.37 mm., 26 ga.50 mm., 26 ga.	25 mm., 30 ga.25 mm., 28 ga.25 mm., 27 ga.37 mm., 27 ga.50 mm., 27 ga.25 mm., 26 ga.50 mm., 26 ga.37 mm., 26 ga.65 mm., 25 ga.75 mm., 23 ga.
Standards Met	Unknown	ISO 13485:2003-07-15ISO 14971:2007-02-01ISO 10993-1:2003AAMI/ANSI/ISO 11137-1:2006AAMI/ANSI/ISO 11137-2:2006AAMI/ANSI/ISO 11137-3:2006ISO 14644-1:1999-05-01ISO 14644-2:2000-09-15ISO 14644-4:2001-04-01ISO/TR 16142:2006-01-15BS EN 980:1996 + A1:1999 + A2:2001ISO 9626:1991 + A1:2001ISO 7864:1993

Non-clinical Testing

Bench Testing consisted of the following:

1. Process Control Used to Control the processes used in manufacturing. The methods used for verifying processes will vary depending on the process to be tested and the type of product the process is used to produce. Process Control Forms used:
- Concentric Needle Sharpening visual examination under microscope and foam test Concentric Core Insertion - visual examination under microscope
- Concentric Needle Continuity audible ohmmeter
- Concentric Needle Pole Isolation audible ohm meter
- Concentric Needle Handle Mold Design Visual and audible ohm meter Concentric Needle Connector Interface - Visual and audible ohm meter
1. Process Verification Process verification is done according to the control process
- established in Process Control Forms above. Process Verification Forms used:
  - Concentric Needle Sharpening
  - Concentric Core Insertion
  - Concentric Needle Continuity
  - Concentric Needle Pole Isolation
  - Concentric Needle Handle Mold Design
  - Concentric Needle Connector Interface
1. Design Verification after Process Verification has been approved, verification is performed using samples from the first production run. The methods used for the Concentric Needle Design are identical to those used in the Process Approval phase above since the process and design output parameters are the same. Design Verification Forms used:
- Concentric Needle Sharpening- visual examination under microscope and foam test Concentric Core Insertion - visual examination under microscope
- Concentric Needle Continuity audible ohmmeter
- Concentric Needle Pole Isolation audible ohmmeter
- Concentric Needle Handle Mold Design Visual and audible ohm meter
- Concentric Needle Connector Interface Visual and audible ohm meter
1. Standards used see comparison chart above.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's seal and the symbol. The seal is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." arranged around the perimeter. The symbol is a stylized representation of a caduceus, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rochester Electro-Medical, Inc. % Mr. Charles C. Berkins CEO 4212 Cypress Gulch Drive Lutz, Florida 33559

JUL 1 5 2008

Re: K080914 Trade/Device Name: Ultrasharp Concentric Needles Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic electromyograph needle electrode Regulatory Class: Class II Product Code: IKT Dated: May 8, 2008 Received: May 21, 2008

Dear Mr. Berkins:

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 for answer 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). and coometre fore, market the device, subject to the general controls provisions of the Act. The r ou may are see your in as of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607), idoomig (DI CFR Part 820); and if applicable, the electronic forul in the quality by neally (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charles C. Berkins

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K080914
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Page 1 of 1

Regulation Number and Section

§ 890.1385 Diagnostic electromyograph needle electrode.

(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).