ULTRASHARP CONCENTRIC NEEDLES

K080914 · Rochester Electro Medical, Inc. · IKT · Jul 15, 2008 · Physical Medicine

Device Facts

• Record ID: K080914
• Device Name: ULTRASHARP CONCENTRIC NEEDLES
• Applicant: Rochester Electro Medical, Inc.
• Product Code: IKT · Physical Medicine
• Decision Date: Jul 15, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

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

Device Story

Ultra Sharp Concentric Needles are disposable, bi-polar/multi-polar electrodes used for recording muscle activity during electromyography (EMG). The device consists of a stainless steel hypodermic outer shell with a centered platinum/iridium inner recording core, featuring a trocar sharpened tip. An electrically insulated molded handle provides contact points for connection to an external EMG machine via a detachable cable (sold separately). The device is intended for use in hospitals or physician offices by trained, certified physicians or under their order. By providing a stable electrical interface with muscles and associated nerves, the needle allows clinicians to capture physiological signals, aiding in the diagnosis of neuromuscular conditions. The device is for single-patient use to prevent cross-contamination.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included microscopic visual examination of bevel convergence, burrs, and point; foam testing for sharpness; electrical continuity and pole isolation testing using an ohmmeter; and examination of needle straightness and length. Risk management and design controls were completed.

Technological Characteristics

Stainless steel hypodermic outer shell; platinum/iridium inner recording core; molded plastic handle. Dimensions vary by model (25mm-75mm length; 23-27 gauge). Passive electrode; no internal energy source. Sterilized via Gamma Irradiation. Standards met: ISO 13485, ISO 14971, ISO 10993-1, AAMI/ANSI/ISO 11137, ISO 14644, ISO 9626, ISO 7864.

Indications for Use

Indicated for recording muscle activity for Electromyography (EMG) applications in adults. For single patient use only.

Regulatory Classification

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).

Predicate Devices

• CONCENTRIC ELECTRODE TYPE #13R01, 13R02 (K895460)
• DANTEC DISPOSABLE CONCENTRIC NEEDLE (931966)
• DISPOSABLE CONCENTRIC NEEDLE ELECTRODE (K924521)
• DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) (K896370)
• CONCENTRIC EMG NEEDLE ELECTRODE (K933795)
• NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODE (K973529)
• RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,23) (K960591)

Submission Summary (Full Text)

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KOROGIY

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## 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. [e-mail]

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 | CONCENTRIC<br>ELECTRODE TYPE<br>#13R01, 13R02 | DANTEC<br>ELECTRONICS, INC. |
| 931966 | IKT | DANTEC DISPOSABLE<br>CONCENTRIC NEEDLE | DANTEC MEDICAL, INC. |
| K924521 | IKT | DISPOSABLE<br>CONCENTRIC NEEDLE<br>ELECTRODE | CHALGREN<br>ENTERPRISES, INC. |
| K896370 | GXZ | DISP. CONCENTRIC<br>NEEDLE ELECTRODE<br>(DCP-30, DCP-45 | CHALGREN<br>ENTERPRISES, INC. |
| K933795 | GXZ | CONCENTRIC EMG<br>NEEDLE ELECTRODE | CADWELL<br>LABORATORIES, INC. |
| K973529 | IKT | NEUROLINE,<br>DISPOSABLE<br>CONCENTRIC NEEDLE<br>ELECTRODE | MEDICOTEST A/S. |
| K960591 | IKT | RE-USABLE BIPOLAR<br>CONCENTRIC<br>NEEDLE(237-XXX-24,23 | CHALGREN<br>ENTERPRISES, INC. |

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### Device Description

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.

#### 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 for<br>Electromyography (EMG)<br>applications. For Single Patient<br>Use only. | Recording muscle activity for<br>Electromyography (EMG)<br>applications. For Single Patient<br>Use only. |
| Target Population | Adults | Adults |
| Design | Outer Hypodermic shell with<br>insulated inner recording core.<br>Recording connections through a<br>molded handle to a detachable<br>connecting cable. | Outer Hypodermic shell with<br>insulated inner recording core.<br>Recording connections through a<br>molded handle to a detachable<br>connecting cable. |
| Materials | Stainless Steel cannula, platinum<br>Or silver core, Molded plastic handle | Stainless Steel cannula, platinum<br>core, Molded plastic handle |
| Performance | Unknown | Testing data: Core Centering & Size;<br>Microscopic visual examination;<br>Sharpening; Microscopic visual<br>examination with special<br>attention to bevel convergence, burrs<br>and point; Electrical continuity of all<br>poles; Electrical isolation of all poles;<br>Needle hypodermic shell examined for<br>straightness and stated length. |
| Sterility | Gamma Irradiation, E-Beam | Gamma Irradiation |
| Biocompatibility | Stainless Steel, Platinum & Silver | Stainless Steel & Platinum |
| Mechanical Safety | Packaged needle covered with a<br>needle cover. | Packaged needle covered with a<br>needle 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, certified<br>physician or by order of a physician | Must be used by a trained, certified<br>physician or by order of a physician |
| Energy Used/Delivered | Not Applicable | Not Applicable |
| Compatibility with Other Devices | Compatibility is achieved through the<br>connecting cable to EMG machines or<br>similar physiological recording devices. | Compatibility is achieved through the<br>connecting cable to EMG machines or<br>similar physiological recording devices. |
| Where Used | Physician's office or Hospitals. | Physician's office or Hospitals. |
| Risk Analysis | Unknown | Risk Management completed 1-30-<br>08 as part of the Design Control<br>Process |
| Design Control | Unknown | Design Control Completed 1-30-08 |
| Electrical Safety | Unknown | Controlled & accounted for with<br>Risk Management. |

#### Substantial Equivalence Comparison

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| Design Control | Unknown | Design Control Completed 1-30-08 | |
|-------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | Unknown | Controlled & accounted for with<br>Risk Management. | |
| Options Offered | 25 mm., 30 ga.<br>30 mm., 28 ga.<br>38 mm., 26 ga.<br>75 mm., 23 ga. | 25 mm., 26 ga.<br>37 mm., 26 ga.<br>50 mm., 26 ga. | 25 mm., 30 ga.<br>25 mm., 28 ga.<br>25 mm., 27 ga.<br>37 mm., 27 ga.<br>50 mm., 27 ga.<br>25 mm., 26 ga.<br>50 mm., 26 ga.<br>37 mm., 26 ga.<br>65 mm., 25 ga.<br>75 mm., 23 ga. |
| Standards Met | Unknown | ISO 13485:2003-07-15<br>ISO 14971:2007-02-01<br>ISO 10993-1:2003<br>AAMI/ANSI/ISO 11137-1:2006<br>AAMI/ANSI/ISO 11137-2:2006<br>AAMI/ANSI/ISO 11137-3:2006<br>ISO 14644-1:1999-05-01<br>ISO 14644-2:2000-09-15<br>ISO 14644-4:2001-04-01<br>ISO/TR 16142:2006-01-15<br>BS EN 980:1996 + A1:1999 + A2:2001<br>ISO 9626:1991 + A1:2001<br>ISO 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
- 2. 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
- 3. 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
- 4. 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone]or [phone] 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(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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