(28 days)
Sure-Point® Midline Stepping and Stabilization System
Not Found
No
The device description focuses on mechanical components for ultrasound probe alignment and seed implantation, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a system to aid in the precise placement of radioactive seeds during brachytherapy procedures, specifically serving to hold an ultrasound transducer and template and facilitate three-dimensional placement. It does not directly provide therapy but rather assists in the therapeutic procedure.
No
The device is described as a system for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy procedures, specifically for holding an ultrasound transducer and template, and facilitating precise three-dimensional placement of radioactive seeds. This is a therapeutic and intervention support device, not one that diagnoses conditions.
No
The device description explicitly details physical hardware components: a Midline Stepping Head, a Midline Articulated Arm, and a Midline Patient Board, which are assembled and used to hold and position an ultrasound transducer and template.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "precision ultrasound probe alignment and radioactive seed implantation in brachytherapy procedures." This describes a surgical or interventional procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device components (Stepping Head, Articulated Arm, Patient Board) are designed to physically manipulate and stabilize instruments during a procedure. They do not perform any analysis or testing of biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological specimens (like blood, urine, tissue, etc.), which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to facilitate a therapeutic procedure, not to diagnose or analyze a sample.
N/A
Intended Use / Indications for Use
Sure-Point® Midline Stepping and Stabilization Systems are indicated for use to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy procedures. A specific application is the treatment of prostate cancer.
The SURE-POINT MIDLINE Stepping and Stabilization System is indicated for use to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy procedures. A specific application is the treatment of prostate cancer.
Product codes
ITX, KXK
Device Description
The Sure-Point Midline Stepping and Stabilization System is comprised of three Components - the Midline Stepping head, Midline Patient Board, and the Midline Articulated Arm. The System is placed on a procedure table utilizing the patient's weight for proper stabilization. The Sure-Point Midline Stepping head is mounted onto the Midline Articulated Arm which in turn is connected to the patient's board utilizing "dovetail connections", clamps and screws. During a brachytherapy procedure, the Midline Stepping head serves to securely hold an ultrasound transducer, and a template, while the locking knob facilitates precise three dimensional radioactive seed implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
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
The appropriate design verification and validation activities for the modification of the SURE-POINT® MIDLINE Stepping and Stabilization System were conducted.
Key Metrics
Not Found
Predicate Device(s)
Sure-Point® Midline Stepping and Stabilization System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
16050724
APR 1 8 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
SUBMITTER INFORMATION: A.
| Submitter's Name: Address: | C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, GA 30014 |
|---|---|
| Contact Person: | Lorraine R. Pata |
| Contact Person's Telephone Number: | 770-784-6160 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | March 11, 2005 |
DEVICE NAME: B.
Trade Name(s):
Common / Usual Name: Classification Names:
Sure-Point® Midline Stepping and Stabilization System Stepping and Stabilization Device 90 ITX - Accessory to Diagnostic, Ultrasound transducer 21 CFR 892.5730
PREDICATE DEVICE NAME: C.
Sure-Point® Midline Stepping and Stabilization System Trade Names:
DEVICE DESCRIPTION: D.
The Sure-Point Midline Stepping and Stabilization System is comprised of three The Sure-Foint Midline Stepping and Classic Needle Needle Needle Template, Components - the Midline Stopping - Locking Knob and the Midline Patient Midline Articulated Am a procedure table utilizing the patient's weight Board. The System is Slaatod on a proper stabilization. The Sure-Point Midline Stepping head is mounted onto the Midline Articulated Arm which in turn is Stepling Thead Is Intounted Unio mating "dovetail connections", clamps and connected to the pations being multing Stepping head serves to screws. Dunny a brachytherapy proceared the same the template, while the Securely Trold an Gitraoound transcal lock facilitates precise three dimensional Midine Articulated Amil was olacement of radioactive seed implantation.
1
Intended Use: E.
Sure-Point® Midline Stepping and Stabilization Systems are indicated for Sure-Folltw Midine Olepping and Grobe alignment and radioative seed
use to allow precision ultrasound probe alignment and radion is the use to allow precision unrasound probo alignments. A specific application is the treatment of prostate cancer.
Technological Characteristics Summary: F.
The subject SURE-POINT® MIDLINE Stepping and Stabilization System have The subject SUNC-FORN - MIDEINE Stopping and fundamental scientific technology as the predicate device.
Performance Data Summary: G.
The appropriate design verification and validation activities for the The appropriate design vehicution and valuation
modification of the SURE-POINT® MIDLINE Stepping and Stabilization System were conducted.
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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lorraine R. Pata Regulatory Affairs Specialist
Re: K050724
APR 1 8 2005
Trade/Device Name: SURE-POINT® MIDLINE Stepping and Stabilization System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: ITX and KXK Dated: March 11, 2005 Received: March 21, 2005
Dear Ms. Pata:
C. R. Bard, Inc
8195 Industrial Blvd.
COVINGTON GA 30014
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w one 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 the enorosate to the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the clayments 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 do not require approval or a provisions of the Act. The general controls provisions of the Act at floor sabject to 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 (Premarket n your do rever to such additional controls. Existing major regulations affecting your Apploval), It they of babled to rederal 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 I toase of devised that i revice complies with other requirements of the Act or any I DA has made a acterininations administered by other Federal agencies. You must comply with all the I caran suitees and regulating, 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) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket nothleation: "The PDA mailig of oassification 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 If you desire specific actied for your development mimbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation emilies, formation on your responsibilities under the Act from the 807.97). Tou may obtain other general missistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bard Urological Division, C.R. Bard, Inc. SURE-POINT® MIDLINE Stepping and Stabilization System Premarket Notification [510(k)]
| 1.3 | Indications for Use Statement | |||
|---|---|---|---|---|
| 510(k) Number (if known): | K050724 |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The SURE-POINT MIDLINE Stepping and Stabilization System is indicated for use to allow The SURE-FOINT MIDENE Otcpling and cradioactive seed implantation in brachytherapy precision - unrasound - alignification is the treatment of prostate cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1/2/96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number |