(61 days)
Not Found
Not Found
No
The summary describes a radio frequency ablation device and explicitly states that AI, DNN, or ML were not found in the document.
Yes.
The device is used for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and uses radio frequency (RF) energy to ablate prostate tissue, indicating a therapeutic purpose.
No
The document states that the TUNA System is "indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)". This indicates a therapeutic, rather than a diagnostic, purpose.
No
The device description explicitly states it is a "Hand Piece" which is a hardware component used to deliver radio frequency energy. The summary also mentions "modifications to the TUNA Therapy Model 8929 Hand Piece device" and "Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device," further confirming it is a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of symptoms due to BPH by ablating prostate tissue. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a delivery system that uses radio frequency energy to ablate tissue. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the TUNA System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Product codes
KNS, GEI
Device Description
The Medtronic TUNA (Transurethral Needle Ablation) Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Medtronic is commercializing the branded product as the PROSTIVA® RF Therapy System which uses precisely focused radio frequency (RF) energy to ablate prostate tissue. The Prostiva RF Therapy Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
men over the age of 50
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
Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device and the device met all design and performance requirements.
Key Metrics
Not Found
Predicate Device(s)
TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
KO82464 Page
August 2008
Prostiva RF Model 8929 Hand Piece Special 510(k) Change Being Effected
OCT 2 7 2008
2. 510(k) Summary
Date Summary Prepared: August 26, 2008 Applicant: Medtronic Neuromodulation 710 Medtronic Pkwy., N.E. Minneapolis, MN 55432-5604 Contact: Jeanmarie Sales Regulatory Affairs Director, Gastro/Uro 763-505-0256 763-505-0258 (fax)
Trade Name: TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece)
Classification Name: 21 CFR 876.4300 (Endoscopic electrosurgical unit and accessories)
Name of Predicate Device: TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece)
Device Description
The Medtronic TUNA (Transurethral Needle Ablation) Therapy is a minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Medtronic is commercializing the branded product as the PROSTIVA® RF Therapy System which uses precisely focused radio frequency (RF) energy to ablate prostate tissue. The Prostiva RF Therapy Model 8929 Hand Piece is the delivery system component of the Prostiva RF Therapy System.
Indications for Use
The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
Performance Standards
No applicable mandatory performance standards or special controls exist for this device.
Substantial Equivalence
The results of the design verification testing indicate that the modified PROSTIVA RF Therapy Model 8929 Hand Piece with handle modifications is substantially equivalent to the currently marketed device. There are no changes in specifications or indications for use.
Image /page/0/Picture/17 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo and the word "Medtronic" is the word "Confidential" in a smaller, non-bold font. The Medtronic logo is a stylized image of a person inside of a circle.
1
Prostiva RF Model 8929 Hand Piece Special 510(k) Change Being Effected August 2008
Summary of Testing
Design verification testing was performed to support modifications to the TUNA Therapy Model 8929 Hand Piece device and the device met all design and performance requirements.
Conclusion
The modified device is substantially equivalent to the currently marketed PROSTIVA RF Therapy Model 8929 Hand Piece based upon design verification test results and the indications for use.
Image /page/1/Picture/7 description: The image shows the Medtronic logo with the word "Confidential" underneath. The Medtronic logo consists of a stylized human figure inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanmarie Sales Regulatory Affairs Director, Gastro/Uro Medtronic, Inc. 710 Medtronic Parkway, N.E. MINNEAPOLIS MN 55432-5604
OCT 2 7 2008
Re: K082464
Trade/Device Name: PROSTIVA® RF Therapy Model 8929 Hand Piece Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Codes: KNS and GEI Dated: August 26, 2008 Received: August 27, 2008
Dear Ms. Sales:
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. Ilsting 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 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.
3
Page 2 - Ms. Sales
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) 276-0115. 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hala Leen
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K082464
Device Name: PROSTIVA® RF Therapy Model 8929 Hand Piece
Indications for Use:
The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use_ X Per 21 CFR 801.109
Over-The-Counter Use
Helene Lemer
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number.