(449 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and electrosurgical function of the electrodes, with no mention of AI or ML capabilities.
No.
Explanation: The device is an accessory (electrode) used with an electrosurgical pencil and generator to deliver radiofrequency energy for cutting, excising, and coagulating tissue during arthroscopic surgical procedures. While it facilitates a therapeutic procedure, the device itself is not providing the direct therapeutic action but rather enabling the delivery of energy.
No
This device is described as an electrosurgical tool that delivers radiofrequency energy to cut, excise tissue, or coagulate blood vessels during surgical procedures. Its function is therapeutic, not diagnostic.
No
The device description clearly details physical components (conductive electrode tip, insulated shaft, conductive post) and their materials and functions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures." This describes a surgical intervention performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a surgical electrode designed to deliver electrical energy for tissue manipulation. This is consistent with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical electrosurgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GEI
Device Description
Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode.
The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.
The Single Use Arthroscopic Electrodes are provided in the following designs:
A. Product Description (Electrode only):
- Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 1. 213.5mm, Hex Lock
- Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 2. 214.5mm, Hex Lock
- Single Use Arthroscopic Angled Blade Electrode, insulated, , Total Length 214.5mm, 3. Hex Lock
-
- Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm, Hex Lock
-
- Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
- Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 6. 214.5mm
- Single Use Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm 7.
-
- Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Hook Teflon coated, Electrode, 90° Angle, insulated, Total Length 213.5mm, Hex Lock
-
-
- Single Use Arthroscopic Hook Teflon coated, Electrode, 45° Angle, insulated, Total Length 214.5mm Hex Lock
-
-
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm Hex lock
-
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm, Hex Lock
-
- Single Use Arthroscopic Hook Teflon coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Arthroscopic Hook Teflon coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm
B. Product Description (Push Button Pencil with electrode):
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated 14.5mm Electrode
C. Product Description (Rocker Button Pencil with electrode):
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, non-insulated, Total Length 214.5mm
Single Use Arthroscopic Electrodes do not have cloud communications, network connection, wireless communication in any form, USB / serial ports / removable media or software upgrades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
"Adults only" use.
Intended User / Care Setting
Not Found
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)
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014 and packaging.
Performance Testing included comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon in saline for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016.
The duty cycle is 10 seconds ON and 5 seconds OFF. This testing demonstrated that the thermal effect and tissue stickiness on the tip of electrode of the subject and predicate devices are substantially equivalent.
Electrical Safety complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)
The proposed device is an external device that contacts tissue/bone/dentin for limited contact duration (less than 24 hours). No biologically significant effect was observed in tests conducted in accordance with ISO 10993 for intracutaneous reactivity, in vitro cytotoxicity, skin sensitization, acute systemic toxicity or pyrogenicity.
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.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2018
Modern Medical Equipment Manufacturing Limited Jerry Cheung Regulatory Manager 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong, China
Re: K170703
Trade/Device Name: Single Use Arthroscopic Electrode (with Pencil) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GEI Dated: April 11, 2018 Received: April 20, 2018
Dear Jerry Cheung:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170703
Device Name
Single Use Arthroscopic Electrode (with Pencil)
Indications for Use (Describe)
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. 510(k) Owner Modern Medical Equipment Manufacturing Limited Name: Address: Modern Medical Equipment Mfg., Ltd. Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung, N.T., Hong Kong, China. Telephone: (852) 2420 9068 Fax: (852) 2481 1234 Contact person: Mr. Jerry Cheung Date of preparation: 27 April, 2018 2. Device Name of Device: Single Use Arthroscopic Electrode (with Pencil) Trade or proprietary name: Single Use Arthroscopic Electrode: Push Button Pencil with Single Use Arthroscopic Electrode Rocker Switch Pencil with Single Use Arthroscopic Electrode Single Use Arthroscopic Electrode; Common or usual name: Push Button Pencil with Single Use Arthroscopic Electrode Rocker Switch Pencil with Single Use Arthroscopic Electrode Classification name: Arthroscope; Electrosurgical, Cutting & Coagulation Device & Accessories Classification Panel: General & Plastic Surgery Product Code: HRX. GEI II Class:
3. Predicate device
Aaron Arthroscopy Electrodes with 510(k) number K020579.
4. Device description
Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material
4
(Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode.
The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.
The Single Use Arthroscopic Electrodes are provided in the following designs:
A. Product Description (Electrode only):
- Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 1. 213.5mm, Hex Lock
- Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 2. 214.5mm, Hex Lock
- Single Use Arthroscopic Angled Blade Electrode, insulated, , Total Length 214.5mm, 3. Hex Lock
-
- Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm, Hex Lock
-
- Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
- Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 6. 214.5mm
- Single Use Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm 7.
-
- Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Hook Teflon coated, Electrode, 90° Angle, insulated, Total Length 213.5mm, Hex Lock
-
-
- Single Use Arthroscopic Hook Teflon coated, Electrode, 45° Angle, insulated, Total Length 214.5mm Hex Lock
-
-
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm Hex lock
-
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm, Hex Lock
-
- Single Use Arthroscopic Hook Teflon coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Arthroscopic Hook Teflon coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm
B. Product Description (Push Button Pencil with electrode):
- Single Use Push Button Pencil with Arthroscopic Hook Electrode, 90°
5
Angle, insulated, Total Length 213.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated
- Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated
14.5mm Electrode
C. Product Description (Rocker Button Pencil with electrode):
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
-
- Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, non-insulated, Total Length 214.5mm
Single Use Arthroscopic Electrodes do not have cloud communications, network connection, wireless communication in any form, USB / serial ports / removable media or software upgrades.
Single Use Arthroscopic Electrode is for "Adults only" use.
DO NOT USE a Single Use Arthroscopic Electrode with port, trocar or cannula. Capacitive coupling may be associated with unintended thermal injury.
5. Intended use
The Single Use Arthroscopic Electrode is intended for use to deliver monopolar radiofrequency energy.
6
6. Indication for use
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
7 Technological characteristic
Single Use Arthroscopic Electrodes have substantially equivalent construction and performance as the predicate devices.
8. Substantial Equivalence
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. .
9. Performance Testing Data
Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014 and packaging.
Performance Testing included comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon in saline for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016.
The duty cycle is 10 seconds ON and 5 seconds OFF. This testing demonstrated that the thermal effect and tissue stickiness on the tip of electrode of the subject and predicate devices are substantially equivalent.
9. Safety and Biocompatibility testing data
Electrical Safety complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)
The proposed device is an external device that contacts tissue/bone/dentin for limited contact duration (less than 24 hours). No biologically significant effect was observed in tests conducted in accordance with ISO 10993 for intracutaneous reactivity, in vitro cytotoxicity, skin sensitization, acute systemic toxicity or pyrogenicity.
10. Conclusion
Based on comparing technological characteristic and performance testing data, the subject device, Single Use Arthroscopic Electrodes is substantially equivalent to predicate device (K020579).