Who is the manufacturer of PROSTIVA RF THERAPY HAND PIECE, MODEL 8929?

Medtronic, Inc. filed the 510(k) submission for PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 (K082464).

What is the FDA product code for PROSTIVA RF THERAPY HAND PIECE, MODEL 8929?

KNS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PROSTIVA RF THERAPY HAND PIECE, MODEL 8929?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PROSTIVA RF THERAPY HAND PIECE, MODEL 8929?

TUNA Therapy Model 8929 Hand Piece (PROSTIVA® RF Therapy Model 8929 Hand Piece).

Who can help prepare an FDA 510(k) submission like PROSTIVA RF THERAPY HAND PIECE, MODEL 8929?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PROSTIVA RF THERAPY HAND PIECE, MODEL 8929

K082464 · Medtronic, Inc. · KNS · Oct 27, 2008 · Gastroenterology, Urology

Device Facts

Record ID	K082464
Device Name	PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
Applicant	Medtronic, Inc.
Product Code	KNS · Gastroenterology, Urology
Decision Date	Oct 27, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Prostiva RF Therapy Model 8929 Hand Piece is a delivery system component of the TUNA (Transurethral Needle Ablation) Therapy System; used for minimally invasive treatment of BPH. Device delivers precisely focused radio frequency (RF) energy to ablate prostate tissue. Operated by clinicians in a clinical setting. Hand piece modifications were implemented to the existing design. Output is thermal ablation of prostate tissue; intended to reduce urinary outflow obstruction. Benefits include minimally invasive symptom relief for BPH patients.

Clinical Evidence

Bench testing only; design verification testing performed to support handle modifications.

Technological Characteristics

Endoscopic electrosurgical unit accessory; RF energy source; hand piece delivery system; modified handle design.

Indications for Use

Indicated for treatment of urinary outflow obstruction symptoms secondary to BPH in men >50 years old with prostate sizes 20-50 cm3.

Regulatory Classification

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.

Predicate Devices

TUNA Therapy Model 8929 Hand Piece (PROSTIVA® RF Therapy Model 8929 Hand Piece)

Related Devices

K113380 — PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR · Medtronic, Inc. · Nov 15, 2012
K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 · Medtronic Vascular · Nov 17, 2005
K101139 — PROSTIVA RF THERAPY MODEL 8929 HAND PIECE · Medtronic, Inc. · May 21, 2010
K011787 — PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE · Vidamed, Inc. · Jul 6, 2001
K142248 — Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope · Urologix, Inc. · Feb 20, 2015

Submission Summary (Full Text)

{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.