(105 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and electrical properties of a disposable needle electrode for EMG, with no mention of data processing, analysis, or algorithms that would typically involve AI/ML.
No
The device is described as "Recording muscle activity for Electromyography (EMG) applications" and its purpose is to "record muscle activity." It is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The intended use explicitly states "Recording muscle activity for Electromyography (EMG) applications." EMG is a diagnostic procedure used to assess the health of muscles and the nerve cells that control them. The device records muscle activity, which is then used by a trained physician for diagnostic purposes.
No
The device description clearly outlines physical hardware components (needles, handle, contact points, cable) and the performance studies focus on the verification of these physical components and manufacturing processes. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Recording muscle activity for Electromyography (EMG) applications." This involves measuring electrical signals directly from the body (in vivo), not testing samples of bodily fluids or tissues outside the body (in vitro).
- Device Description: The device is a needle designed to be inserted into muscle tissue to record electrical activity. This is a direct interaction with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device is an in vivo diagnostic device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only. Patient population: Adults.
Product codes (comma separated list FDA assigned to the subject device)
IKT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscles and associated Nerves
Indicated Patient Age Range
Adults
Intended User / Care Setting
Must be used by a trained, certified physician or by order of a physician
Physician's office or Hospitals.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing consisted of the following:
- 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
- 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K895460, 931966, K924521, K896370, K933795, K973529, K960591
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 | CONCENTRIC | |
| ELECTRODE TYPE | |||
| #13R01, 13R02 | DANTEC | ||
| ELECTRONICS, INC. | |||
| 931966 | IKT | DANTEC DISPOSABLE | |
| CONCENTRIC NEEDLE | DANTEC MEDICAL, INC. | ||
| K924521 | IKT | DISPOSABLE | |
| CONCENTRIC NEEDLE | |||
| ELECTRODE | CHALGREN | ||
| ENTERPRISES, INC. | |||
| K896370 | GXZ | DISP. CONCENTRIC | |
| NEEDLE ELECTRODE | |||
| (DCP-30, DCP-45 | CHALGREN | ||
| ENTERPRISES, INC. | |||
| K933795 | GXZ | CONCENTRIC EMG | |
| NEEDLE ELECTRODE | CADWELL | ||
| LABORATORIES, INC. | |||
| K973529 | IKT | NEUROLINE, | |
| DISPOSABLE | |||
| CONCENTRIC NEEDLE | |||
| ELECTRODE | MEDICOTEST A/S. | ||
| K960591 | IKT | RE-USABLE BIPOLAR | |
| CONCENTRIC | |||
| NEEDLE(237-XXX-24,23 | CHALGREN | ||
| ENTERPRISES, INC. |
1
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 | |
| Electromyography (EMG) | ||
| applications. For Single Patient | ||
| Use only. | Recording muscle activity for | |
| Electromyography (EMG) | ||
| applications. For Single Patient | ||
| Use only. | ||
| Target Population | Adults | Adults |
| Design | Outer Hypodermic shell with | |
| insulated inner recording core. | ||
| Recording connections through a | ||
| molded handle to a detachable | ||
| connecting cable. | Outer Hypodermic shell with | |
| insulated inner recording core. | ||
| Recording connections through a | ||
| molded handle to a detachable | ||
| connecting cable. | ||
| Materials | Stainless Steel cannula, platinum | |
| Or silver core, Molded plastic handle | Stainless Steel cannula, platinum | |
| core, Molded plastic handle | ||
| Performance | Unknown | Testing data: Core Centering & Size; |
| Microscopic visual examination; | ||
| Sharpening; Microscopic visual | ||
| examination with special | ||
| attention to bevel convergence, burrs | ||
| and point; Electrical continuity of all | ||
| poles; Electrical isolation of all poles; | ||
| Needle hypodermic shell examined for | ||
| 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 | |
| needle cover. | Packaged needle covered with a | |
| 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 | |
| physician or by order of a physician | Must be used by a trained, certified | |
| physician or by order of a physician | ||
| Energy Used/Delivered | Not Applicable | Not Applicable |
| Compatibility with Other Devices | Compatibility is achieved through the | |
| connecting cable to EMG machines or | ||
| similar physiological recording devices. | Compatibility is achieved through the | |
| connecting cable to EMG machines or | ||
| similar 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 Control | ||
| Process | ||
| Design Control | Unknown | Design Control Completed 1-30-08 |
| Electrical Safety | Unknown | Controlled & accounted for with |
| Risk Management. |
Substantial Equivalence Comparison
2
| Design Control | Unknown | Design Control Completed 1-30-08 | |
|---|---|---|---|
| Electrical Safety | Unknown | Controlled & accounted for with | |
| Risk 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 13485:2003-07-15 | |
| ISO 14971:2007-02-01 | |||
| ISO 10993-1:2003 | |||
| AAMI/ANSI/ISO 11137-1:2006 | |||
| AAMI/ANSI/ISO 11137-2:2006 | |||
| AAMI/ANSI/ISO 11137-3:2006 | |||
| ISO 14644-1:1999-05-01 | |||
| ISO 14644-2:2000-09-15 | |||
| ISO 14644-4:2001-04-01 | |||
| ISO/TR 16142:2006-01-15 | |||
| BS EN 980:1996 + A1:1999 + A2:2001 | |||
| ISO 9626:1991 + A1:2001 | |||
| ISO 7864:1993 |
Non-clinical Testing
Bench Testing consisted of the following:
-
- 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
-
- 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
-
- 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
-
- Standards used see comparison chart above.
3
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.
4
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
5
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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