(44 days)
Not Found
No
The document describes a standard radiofrequency electrosurgical generator and accessories. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the power delivery and intended surgical applications.
Yes
The device is intended for coagulation, cutting, and ablation of soft tissues in various surgical procedures, which are therapeutic actions.
No
The device description clearly states its purpose is for "coagulation, cutting and ablation of soft tissues" and "cut, coagulate and vaporization (ablation) of soft tissue", which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states that the system consists of a radiofrequency generator, hand-pieces, and electrodes, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ORION-I EMF System is for "general surgical purposes in coagulation, cutting and ablation of soft tissues." This describes a device used on the patient's body during a surgical procedure.
- Device Description: The description details a "radiofrequency generator and accessories, sterile, single-use hand-pieces and sterile, single-use electrodes" that deliver energy to "cut, coagulate and vaporization (ablation) of soft tissue." This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to perform tests on these types of samples to diagnose conditions, monitor treatment, or screen for diseases.
Therefore, the ORION-I EMF System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORION-I EMF System is intended to be used for general surgical purposes in The Ortion FEM Oyelowanonization (ablation) of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Dovios Doodlip.com and accessories, sterile, single-use hand-pieces and sterile, single-use electrodes. The and accessementor is a line-voltage powered, bipolar radiofrequency generator capable of delivering up to 16 watts of power at the electrode tip. The ORION-I utilizes controlled of dollivering up to 10 waste of perfor was and vaporization (ablation) of soft tissue during a variety of electrosurgical procedures in general surgical use, including orthopedic, arthroscopic, spinal, and neurosurgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment.
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)
Not Found
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.
K001986, K001407, K001588, K992581, K982176
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) Summary
AUG 2 2 2001
Ortho Development Corporation ORION-I EMF System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K012129 |
|---|---|
| -------------------------------- | --------- |
A. Submitter:
Ortho Development Corporation 106 West 12200 South Draper, UT 84020
Phone: (801) 553-9991 (801) 553-9993 Fax:
Carol Freasier Contact: Regulatory Affairs
Date Prepared: June 22, 2001
- B. Device Names:
ORION-I EMF System Trade Name: Electrosurgical generator and accessories Common/usual Name: Electrosurgical and Coagulation Unit and Accessories Classification Name:
C. Predicate Devices:
.
- K001986, K001407 Ellman Surgitron IEC II RF generator .
- K001986 Ellman Surgitron Hand-pieces ●
- K982176 Kirwan Surgical Hand-pieces .
- K982176 Kirwan Surgical Electrodes .
D. Device Description:
Dovios Doodlip.com and accessories, sterile, single-use hand-pieces and sterile, single-use electrodes. The and accessementor is a line-voltage powered, bipolar radiofrequency generator capable of delivering up to 16 watts of power at the electrode tip. The ORION-I utilizes controlled of dollivering up to 10 waste of perfor was and vaporization (ablation) of soft tissue during a variety of electrosurgical procedures in general surgical use, including orthopedic, arthroscopic, spinal, and neurosurgical procedures.
1
- E. Intended Use:
The ORION-I EMF System is intended to be used for general surgical purposes in The Ortion FEM Oyelowanonization (ablation) of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications
The use of the ORION-I EMF System is contraindicated, when in the judgment of the r he use of the Ortrol rrincedure would be contrary to the best interest of the patient.
- F. Comparison with the Predicate Device:
Oompanson with the Prodited between the Ortho Development ORION-I EMF System There are no orghineant anversely affect the use of the use of the device. The EMF and the prodicate do food which treatle predicate devices in design, function, materials, and indications for use/intended use.
2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a flowing, calligraphic style.
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ortho Development Corporation c/o Michael Kwan, Ph.D. Principal Reviewer and Program Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050
Re: K012129
Trade/Device Name: ORION-1 EMF System Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: August 3, 2001 Received: August 10, 2001
Dear Dr. Kwan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Michael Kwan, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
L. Mark N. Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO12129 510(k) Number (if known): __
Device Name: ORION-I EMF System
Indications for Use:
The ORION-I EMF System is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, curring and ablation of ook abouting rocedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle.
The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications
The use of the ORION-I EMF System is contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
for Mark N Wilkerson
(Division Sign-Off)
ivision of General, Restorative d Neurological Devices
Number _**_$\qquad$ $KO{12/3}9$
(Optional Format 1-2-96)