REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
Device Facts
| Record ID | K130282 |
|---|---|
| Device Name | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT |
| Applicant | Remington Medical, Inc. |
| Product Code | KNW · Gastroenterology, Urology |
| Decision Date | May 13, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.
Device Story
CentreFire 22 Biopsy Instrument is semi-automatic, reusable, spring-loaded mechanical device; used with Remington Medical NAC Biopsy Needles to obtain prostate core biopsy samples. Device features anodized aluminum body; proximal and distal carriages with stainless steel pins; stainless steel springs for propulsion; mechanical latch mechanism for retention. Operation involves two-handed sequential cocking; automatic safety mechanism included. Used in clinical settings by healthcare professionals. Device provides mechanical energy to drive biopsy needle into tissue; output is core tissue sample for diagnostic evaluation. Benefits include consistent, reliable tissue sampling for prostate biopsy procedures.
Clinical Evidence
No clinical testing was required. Substantial equivalence supported by non-clinical performance studies, including needle excursion (penetration depth) and biopsy sampling (quality/consistency), and reuse/reprocessing validation studies.
Technological Characteristics
Reusable, spring-loaded, semi-automatic mechanical biopsy instrument. Materials: Anodized aluminum body, plastic needle sleds/carriages with stainless steel pins, stainless steel propulsion springs. Dimensions/form factor: Handheld. Energy source: Mechanical (spring-loaded). Reprocessing: Manual cleaning and gravity displacement steam sterilization (autoclave).
Indications for Use
Indicated for obtaining multiple core samples from the prostate. Not intended for bone.
Regulatory Classification
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Predicate Devices
- Medical Device Technologies, Inc. Ultra (K962969)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Remington Medical, Inc. The logo consists of a stylized, geometric shape on the left, resembling a cube with the letters 'R' and 'M' integrated into its design. To the right of the geometric shape is the text "Remington Medical, Inc." in a bold, sans-serif font. The overall design is simple and professional, conveying a sense of stability and innovation.
### Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument
MAY 1 3 2013
| Preparation Date | March 4, 2013 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Remington Medical, Inc.<br>6830 Meadowridge Court,<br>Alpharetta, GA, USA 30005<br><br>Registration Number: 1056553<br>Owner/Operator Number: 9006473 |
| Contact Person | Caitlin Senter, MS, RAC<br>Regulatory Affairs Manager<br>770-888-8520, extension 207<br>caitlins@remmed.com |
| Trade Proprietary<br>Name(s) | Remington Medical CentreFire 22 Biopsy Instrument |
| Common Name (s) | Biopsy Instrument |
| Classification Name | 21 CFR 876.1075 (Instrument, Biopsy); Product Code: KNW |
| Device Class: | Class II |
#### 510(k) Summary
#### Legally Marketed Device to Which Substantial Equivalence is Claimed:
Medical Device Technologies, Inc. Ultra (K962969)
#### Description of the Device:
The Remington Medical (RMI) CentreFire 22 Biopsy Instrument is a semi-automatic, reusable, spring-loaded mechanical device that is designed to be used with Remington Medical NAC Biopsy Needles to obtain core biopsy samples from the prostate.
#### Intended Use/Indications for Use
The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a stylized black square with the letters "RM" inside, followed by the words "Remington" and "Medical, Inc." in a bold, sans-serif font. The logo is simple and professional, and it is likely used to represent the company's brand.
#### Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument
#### Technological Characteristics:
The technological characteristics (design, specifications, and performance) of the subject device and the predicate device are substantially equivalent.
| | Subject Device:<br>Remington Medical CentreFire 22<br>Biopsy Instrument | Predicate Device:<br>Medical Device Technologies Ultra,<br>a.k.a. MANAN PRO-MAG™ ULTRA<br>(K962969) |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | Class II |
| FDA Product Code | KNW | KNW |
| Regulation | 21 CFR 876.1075 (Instrument, Biopsy) | 21 CFR 876.1075 (Instrument, Biopsy) |
| Indications for Use<br>Statement | The Remington Medical CentreFire 22<br>Biopsy Instrument is used to obtain multiple<br>core samples from the prostate. It is not<br>intended for bone. | The Ultra™ Biopsy Device is used to<br>obtain multiple core samples from soft<br>tissue such as the liver, kidney, prostate,<br>breast, and various soft tissue lesions. It<br>is not intended for bone. |
| Configuration | Reusable Biopsy Instrument for use with<br>disposable biopsy needle assembly | Reusable Biopsy Instrument for use with<br>disposable biopsy needle assembly |
| Needle Mounting<br>Method /<br>Compatible<br>Needles | Proximal and Distal Carriages grooved to<br>allow insertion of Biopsy Needles | Proximal and Distal Carriages grooved to<br>allow insertion of Biopsy Needles |
| Cocking Method | Two-handed sequential operation | Two-handed sequential operation |
| Needle Sled<br>(Carriage) Material | Plastic with stainless steel pins | Plastic with stainless steel pins |
| Needle Sled<br>(Carriage)<br>Propulsion | Stainless steel spring, one per sled/carriage | Stainless steel spring, one per sled |
| Cocked Sled<br>(Carriage)<br>Retention Method | Mechanical latch mechanism in instrument<br>(Distal and Proximal) | Mechanical latch mechanism in<br>instrument |
| Body Material | Aluminum (anodized) | Aluminum (anodized) |
| Guards/Safety | Automatic Safety | Automatic Safety |
| Reprocessing<br>Method(s) | Manual Cleaning<br>Gravity Displacement Steam Sterilization<br>(Autoclave) | Manual Cleaning<br>Gravity Displacement Steam Sterilization<br>(Autoclave)* |
Additional reprocessing methods were provided in the IFU for the predicate device but were not included in the subject device IFU
#### Performance Data:
The Remington Medical CentreFire 22 Biopsy Instrument was evaluated in the following nonclinical performance studies: Needle Excursion (Penetration Depth) and Biopsy Sampling (Quality/Consistency).
Results of the performance testing demonstrates that the materials chosen, the manufacturing process and the design of the Remington Medical CentreFire 22 Biopsy Instrument meet the established requirements necessary for consistent performance during its intended use. The performance data also demonstrates that the Remington Medical CentreFire 22 Biopsy Instrument performs equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a black square with the letters "RMI" in white, and the words "Remington Medical, Inc." in black text to the right of the square. The text is in a bold, sans-serif font.
### Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument
Reuse/Reprocessing validations were performed on the Remington Medical CentreFire 22 Biopsy Instrument to ensure appropriate cleaning and sterilization methods for the end user.
Results of the reuse/reprocessing validations demonstrates that the Remington Medical CentreFire 22 Biopsy Instrument meets the established requirements necessary for consistent reprocessing.
#### Clinical testing:
No clinical testing was required.
#### Conclusion:
The results of the non-clinical testing demonstrated that the subject device, Remington Medical CentreFire 22 Biopsy Instrument, is substantially equivalent to the predicate device, Medical Device Technologies, Inc. Ultra, with respect to intended use, materials, design, and technological characteristics.
{3}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
Remington Medical, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K130282
Trade/Device Name: Remington Medical CentreFire 22 Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 1, 2013 Received: May 7, 2013
Dear Mr. Job:
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.
{4}------------------------------------------------
Page 2 - Mr. Mark Job
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of the letters "RMI" stacked on top of each other inside of a black square. To the right of the logo is the text "Remington Medical, Inc."
## Indications for Use
510(k) Number (if known): _ K130282
Device Name: Remington Medical CentreFire 22 Biopsy Instrument
#### Indications for Use:
The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.
Prescription Use X
AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
## Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number_ K130282
Page _1_ of _1
