(13 days)
Not Found
No
The device description focuses on mechanical manipulation and support of an ultrasound probe, with no mention of image processing, AI, or ML.
No
This device is described as an "adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes" used for "pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement." Its function is to assist in imaging, not to directly treat a disease or medical condition.
No
The device is described as an "adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes," which aids in imaging, but does not itself provide a diagnosis. Its function is to facilitate the use of an imaging probe, which then generates images used for diagnosis by a separate system or clinician.
No
The device description explicitly states it is an "adjustable support and manipulation apparatus and system" made of physical materials (Delrin and Aluminum), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This device is used to support and manipulate an ultrasound probe during an imaging procedure on a patient. It does not analyze blood, urine, tissue, or any other bodily fluid or sample in vitro (outside the body).
- The description clearly states its function is to assist with transrectal ultrasound imaging. This is an in vivo (within the body) imaging technique.
- The materials and function described are consistent with a medical device used for procedural support, not for laboratory analysis.
The information provided describes a device that is an accessory to an ultrasound imaging system, designed to improve the accuracy and control of the ultrasound probe during a procedure. This falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy.
This device is indicated for use in adult males with known or suspected prostate cancer.
Product codes (comma separated list FDA assigned to the subject device)
90 ITX
Device Description
This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes.
Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units.
Reusable, non-sterile.
Delrin and Aluminum
Manually-powered, mechanical brachytherapy system designed to provide pre-insertion fixation of ultrasound imaging probes, radiologic stepping units and needle guide templates used during prostatic brachytherapy. This system also facilitates accurate positioning of the ultrasound imaging probe, and a guide for needles carrying a radioactive seed for implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate
Indicated Patient Age Range
adult males
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 (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.
K905198 & K914945, K875241, K905198 & K914945, K850571
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Page 27
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII.
Submitter's Name A.
JUL 2 9 1997
-
- Address
Barzell-Whitmore Maroon Bells, Inc. 1921 Waldemere Street, Suite 310 Sarasota, Florida 34239
- Address
-
- Phone Number
(941) 917-8493
- Phone Number
-
- Contact Person
Willet F. Whitmore, M.D.
- Contact Person
-
- Summary Preparation Date
June 23, 1997
- Summary Preparation Date
Device Name B.
-
- Trade/Proprietary Name
BRACHYSTEPPER Stepping Unit BRACHYSTEPPER Needle Template Guide BRACHYSTAND Support and Manual Adjustment Accessory
- Trade/Proprietary Name
-
- Common/Usual Name
Ultrasonic Pulsed Echo Imaging System and Accessories
- Common/Usual Name
Manual Radionuclide Applicator System and Accessories
-
- Classification Name
Ultrasonic Pulsed Echo Imaging System and Accessories
- Classification Name
Manual Radionuclide Applicator System and Accessories
1
Predicate Device C.
- なと思い
-
- The BRACHYSTEPPER Stepping Unit is substantially-equivalent to the following legally-marketed devices ("Predicate Devices"):
Device Name: | B & K Stepper |
---|---|
Manufacturer: | Brnel & Kjaer Medical |
510(k) Number: | K905198 & K914945 |
Substantial Equivalence Date: | 8/28/91 & 6/26/92 |
Civco Ultra-Step Device Name: Civco Instruments Manufacturer: Unknown 510(k) Number: Unknown Substantial Equivalence Date:
-
- Predicate Devices for the BRACHYSTEPPER Needle Guide Template are:
Civco Seed Implant Needle Guide Device Name: Civco Medical Instruments Manufacturer: K875241 510(k) Number: Substantial Equivalence Date: 4/14/88
- Predicate Devices for the BRACHYSTEPPER Needle Guide Template are:
Device Name: | B & K Stepper Matrix |
---|---|
Manufacturer: | Brnel & Kjaer Medical |
510(k) Number: | K905198 & K914945 |
Substantial Equivalence Date: | 8/28/91 & 6/26/92 |
-
- Predicate Device for the BRACHYSTAND Support and Manual
Adjustment Accessory for the brachytherapy system are:
- Predicate Device for the BRACHYSTAND Support and Manual
Device Name: | "Martin" Immobilizing Device |
---|---|
Manufacturer: | Mick Radio-Nuclear Instruments, Inc. |
510(k) Number: | K850571 |
Substantial Equivalence Date: | 3/26/85 |
Device Name: | Ultra-Step Ultrasound Probe/Stepper |
Fixation Device | |
Manufacturer: | Civco Medical Instruments Co., Inc. |
510(k) Number: | Unknown |
Substantial Equivalence Date: | Unknown |
1
2
Device Description D.
-
- Function
This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes.
- Function
-
- Scientific Basis
Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units.
- Scientific Basis
-
- Significant Physical/Performance Characteristics
- a) Design
Reusable, non-sterile.
-
Materials b)
Delrin and Aluminum -
c) Physical Properties
Not Applicable
E. Intended Use Statement
-
- Disease/Conditions
Volume determination of prostate and radioactive seed implantation during prostatic brachytherapy.
- Disease/Conditions
-
- Patient Population
Males with suspected or known prostate cancer.
- Patient Population
3
i F. Technological Characteristics Summary
Manually-powered, mechanical brachytherapy system designed to provide pre-insertion fixation of ultrasound imaging probes, radiologic stepping units and needle guide templates used during prostatic brachytherapy. This system also facilitates accurate positioning of the ultrasound imaging probe, and a guide for needles carrying a radioactive seed for implantation.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH" are written in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barzell-Whitmore Maroon Bells, Inc. c/o Marian Harding Cochran Regulatory Consultant ACCUREG, Inc. 300 NW 82nd Avenue, Suite 402 Plantation, FL 33324
Re: K972672
Brachystepper Stepping Unit/Needle Guide Template Brachystand Support and Manual Adjustment Accessory Dated: July 14, 1997 Received: July 16, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Cochran:
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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUL 2 9 1997
If your device is classified (see above) into either class II (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h. Liao Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
: INDICATIONS FOR USE STATEMENT IX.
510(k) Number (if known): K972672
Brachystepper Device Name: Stepping Unit ( Needle emplate Bruchy stand Manual Support and Indications for Use:
This device is indicated for use in adult males with known or suspected prostate cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K972672
(Optional Format 1-2-96)