(486 days)
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The device appears to be a standard radiofrequency ablation system controlled by the user.
Yes
The device is used for "thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue," which describes a therapeutic intervention to treat a medical condition.
No
The device is described as an electrosurgical device used for thermal coagulation and ablation of nerve tissue. Its purpose is to treat or ablate, not to diagnose. While it can "locate" nerves, this is in the context of preparing for ablation, not for making a diagnosis.
No
The device description explicitly states it is a hand-held Bi-Polar Radiofrequency battery operated controller (Erase Pen) and a single use, sterile detachable electrode cartridge system (Erase Tip), indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a "hand-held Electrosurgical Device to locate and ablate nerves." This further reinforces its use in a surgical or interventional setting.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. IVDs are specifically designed for this type of testing.
Therefore, the Erase Pen and Erase Tip system is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Erase Pen and Erase Tip (Single use Sterile Detachable Electrode Cartridge system) is intended to create radiofrequency (RF) heat lesion in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
Product codes
GXD, GXI
Device Description
The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerve tissue, peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians in hospital or clinical setting.
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)
All necessary testing was performed on the Erase Pen Model HC-0001 and Erase Tip (Single use Sterile Detachable on the Life Life Life Life Fer Model 110-0001 and Erate The (Single is substantially ogying and the Cartridge system) Model CS-0001 to ensure that the is substantially equivalent to the overlies devices and to ensure that the product raise new issues recording of the sub-cess and to ensure that the new device does not raise new issues regarding safety and effectiveness
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).
0
Cheng Medical Corporation
510(k) Notification
Erase Pen and Erase Tip System for Nerve Ablation (Models HC-0001 and CS-0001)
APPENDIX A: 510(k) SUMMARY
510(k) SUMMARY
OCT - 6 2011
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant A.
Cheng Medical Corporation. 12945 Saratoga Avenue Saratoga, CA 95070 Telephone: (408) 255-3223 Fax: (408) 255-3957
в. Contact Person
Mary P. Gallup Regulatory Affairs Consultant Hantel Technologies, Inc. Telephone: (510) 441-4017
C. Date Prepared
06/04/2010
D. Device Name
Trade Name: Model HC-0001 Erase Pen Model CS-0001 Erase Tip Regulation Number: 21 CFR 882.4400 and 21 CFR 882.4725 Regulation Number: Radiofrequency Lesion Generator and Lesion Probe Regulation Class: II Product Code: GXD, GXI
แ่ Device Description
The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.
F. Intended Use
The Erase Pen and Erase Tip (Single use Sterile Detachable Electrode Cartridge system) is intended to create radiofrequency (RF) heat lesion in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
The Erase Pen and Erase Tip (Single use Sterile Detachable Electrode Cartridge system) ™ Last update: 10/03/2011
1
STATES AND
Cheng Medical Corporation
Erase Pen and Erase Tip System for Nerve Ablation (Models HC-0001 and CS-0001)
Substantial Equivalence G.
The Erase Pen Model HC-0001 and Erase Tip Model CS-0001 is substantially equivalent in the following technological ways to the identified predicate device: Radionic's RFG-3C (K982489) system.
- � Indication For Use
- RF Energy Type Bi Polar �
- Functional (stimulation and ablation) ●
- Probe Type (single use) .
Erase Pen Operating Characteristics compared with predicate device
| Parameter | Erase Pen | Radionics RFG-3C |
|---|---|---|
| a. Maximum voltage deliverable, Vp-p | 56 into 2000Ω and 3000Ω load | 200 into 2000Ω load* |
| b. Maximum current deliverable, amps | 0.18 into 100Ω load | 0.70 into 100Ω load |
| c. Maximum power deliverable, watts | 3.5 into 100Ω load | 50 into 100Ω load |
| d. Maximum voltage accessible, Vp-p | 71 | 161 |
| e. Maximum current accessible, amps | 0.20 | 1.17 |
| f. Maximum power accessible, watts | 5 | 68 |
| g. Frequency of RF energy, kHz | 460+/-5% | 500+/-10% |
| h. Shape of the waveform during RF ablation | sinusoidal | sinusoidal |
| i. Shape of the waveform during Tissue Stimulation | 200µs one-shot pulse (monophasic square wave) | 200µs one-shot pulse (monophasic square wave) |
| j. Impedance cutoffs, ohms | 20 to 220 | 50 to 5000 |
| k. Maximum current limit, amps | 0.18 | 0.70 |
Note: The set output level Erase Pen and adjustable output level Radionics RF generators would have an output power equivalence when the Radionics RFG-3C is at a setting of 3 to 5, depending on the tissue impedance.
- Information not available for the maximum voltage deliverable of the Radionics RFG-3C into a 3000Ω impedance.
H. Device Testing Results and Conclusion
All necessary testing was performed on the Erase Pen Model HC-0001 and Erase Tip (Single use Sterile Detachable on the Life Life Life Life Fer Model 110-0001 and Erate The (Single
is substantially ogying and the Cartridge system) Model CS-0001 to ensure that the is substantially equivalent to the overlies devices and to ensure that the product
raise new issues recording of the sub-cess and to ensure that the new device does not raise new issues regarding safety and effectiveness
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20993-0002
Cheng Medical Corporation c/o Mary Pascual Gallup Vice President of Regulatory Affairs, Consultant Hantel Technologies, Inc. 12945 Saratoga Avenue Saratoga, California 95070
- 6 2011
Re: K101592
Trade/Device Name: Erase Hand-held Controller and Erase Single Use Electrode Cartridge System Regulation Number: 21 CFR 882,4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: Class II Product Code: GXD Dated: September 28, 2011 Received: September 30, 2011
Dear Ms. Pascual Gallup:
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.
3
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 practive 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 Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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.
Kesia Alexander
$\int_a^b$
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Cheng Medical Corporation
510(k) Notification
Erase Pen and Erase Tip System for Nerve Ablation (Models HC-0001 and CS-0001)
SECTION 4: INDICATION FOR USE STATEMENT
Indications for Use
510(k) Number (if known): {{ 0 (5922
Device Name:
Model HC-0001 The Erase Pen Model CS-0001 The Erase Tip
Indications for Use:
Page 1 of 1_
The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.
Prescription Use _Yes_and/or Over-The-Counter Use _ No
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101592
The Erase Pen and Erase Tip (Single use Sterile Detachable Electrode Cartridge system) ™
Page 12 Last update: 10/03/2011