(90 days)
Not Found
No
The document describes a surgical ablation probe that delivers microwave energy. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is purely based on delivering energy and mechanically adjusting the antenna position.
Yes
The device is intended for the "surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles" by inducing "thermal necrosis in the targeted tissues," which treats a medical condition.
No
The device is described as a surgical ablation probe that directs microwave energy to ablate tissue, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical, sterile, hand-held surgical ablation probe with a cable, hand grip, hypotube, sheath, and antenna. This is a hardware device, not software only.
Based on the provided text, the FLEX 10 Accessory is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles." This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on samples taken from the patient's body.
- Device Description: The device is described as a "surgical ablation probe" that directs microwave energy into target tissue. This aligns with a surgical tool used for treatment, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue biopsies, etc.) or providing diagnostic information.
In summary, the FLEX 10 Accessory is a surgical device used for therapeutic purposes (tissue ablation), not a diagnostic device used for analyzing samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.
Product codes
OCL, NEY
Device Description
The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Microwave Generator into the target tissue. The FLEX 10 Accessory is a sterile, hand-held, single-use, surgical ablation device. The ablative microwave energy emanates from an antenna contained in the ablation sheath at the distal end of the device.
The FLEX 10 Accessory has a flexible 2 m long insulated coax cable that attaches the Probe to the Microwave Generator output cable. The flexible cable is attached to a 24 cm long hand grip, followed by a 15 cm section of stainless steel hypotube, followed by a highly flexible PTFE ablation sheath, which contains the movable microwave energy delivery antenna. The end of the ablation sheath is attached to a PEBAX positioning sheath and sutures to aid in the proper placement of the ablating sheath. Moving the sliding ring on the hand grip moves the antenna to discrete numbered locations in the ablating sheath. The position of the antenna within the ablating sheath is displayed to the user by the position indicator of the sliding ring on the hand grip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, in addition to striated, cardiac and smooth muscles.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical
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
The results of bench testing and biocompatibility testing support the substantial equivalence claims of the FLEX 10 Accessory for the AFx Microwave Ablation System in the above indication. The animal testing demonstrated the reliability of the sliding antenna concept.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Afx, Inc. c/o Ms. Nancy Norris Program Director 47929 Fremont Boulevard Fremont, CA 94538
Re: K013946
Trade/Device Name: FLEX 10 Accessory for the Afix Microwave Ablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgicual unit and accessories Regulatory Class: II (two) Product Code: OCL, NEY Dated: November 28, 2001 Received: November 29, 2 001
Dear Ms. Norris:
This letter corrects our substantially equivalent letter of February 27, 2002.
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 (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.
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.
1
Page 2 - Ms. Nancy Norris
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); good manufacturing practice 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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
eegmell.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
AFx inc.
FLEX 10 Ablation Probe Accessory Premarket Notification 510(k)
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K 013946
Device Name:
FLEX 10 Ablation Probe Accessory for the AFx Microwave Ablation System
Indications for Use
The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.
Mark A. Mckinnon
Division Sign-Off) Orvision of General, Restorative and Neurological Devices 013946 (Division Sign-Cam Division of General. 1 451 and Neurological tren
210(!
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH/Office of Device Evaluation (ODE)
OR
Prescription Use \ (Per 21 CFR 801.109)
Over-the-Counter Use (Optional Format 1-2-96)
CONFIDENTIAL
Page 1-4
3
SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K 013946
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92
Contact Person Nancy Norris
FEB 2 7 2002
Program Manager AFx inc. 47929 Fremont Blvd Fremont, CA 94538 (510) 651-7430 (510) 651-7061 fax
Device Name
Trade Name: FLEX 10 Accessory for the AFx Microwave Ablation System Common Name: None Classification Name: Cryosurgical unit and accessories (21 CFR 878.4350);
Predicate Devices
| AFx Microwave Ablation System and Accessories | K003978 |
|---|---|
| CryoGen Cardiac Cryosurgery System | K974320 |
| Heartport Maze System: Cryoprobe Set | K970496 |
Device Description
The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Microwave Generator into the target tissue. The FLEX 10 Accessory is a sterile, hand-held, single-use, surgical ablation device. The ablative microwave energy emanates from an antenna contained in the ablation sheath at the distal end of the device.
The FLEX 10 Accessory has a flexible 2 m long insulated coax cable that attaches the Probe to the Microwave Generator output cable. The flexible cable is attached to a 24 cm long hand grip, followed by a 15 cm section of stainless steel hypotube, followed by a highly flexible PTFE ablation sheath, which contains the movable microwave energy delivery antenna. The end of the ablation sheath is attached to a PEBAX positioning sheath and sutures to aid in the proper placement of the ablating sheath. Moving the sliding ring on the hand grip moves the antenna to discrete numbered locations in the ablating sheath. The position of the antenna within the ablating sheath is displayed to the user by the position indicator of the sliding ring on the hand grip.
Indications for Use
The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.
4
510(k) Summary - continued
Testing in Support of Substantial Equivalence Determination
The results of bench testing and biocompatibility testing support the substantial equivalence claims of the FLEX 10 Accessory for the AFx Microwave Ablation System in the above indication. The animal testing demonstrated the reliability of the sliding antenna concept.
Substantial Equivalence Conclusion
Substantial equivalence is based on the fact that the FLEX 10 Accessory for the AFx Microwave Ablation System has equivalent data-based intended uses as the predicate AFx Microwave Ablation System with its LYNX and FLEX Ablation Probe Accessories. There are no significant technological differences between the FLEX 10 and cleared microwave ablation probes. There are no new questions of safety or efficacy raised by the AFx Microwave Ablation System with any of its ablation probes vis -a-vis the predicate cryogenic ablation devices. Therefore, it can be concluded that the FLEX 10 Ablation Probe Accessory for the AFx Microwave Ablation System is substantially equivalent to the predicate devices.