(77 days)
No
The summary describes a biopsy kit with a needle guide and needle, intended for use with an ultrasound system. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical components and their performance in obtaining tissue samples.
No
The device is a biopsy kit used for performing targeted biopsies, which is a diagnostic procedure, not a therapeutic one. It is used to collect tissue for examination, not to treat a condition.
No
Explanation: The device is described as a biopsy kit, including a needle guide and biopsy needle, intended for performing ultrasound-guided transrectal biopsies of the prostate. Biopsies are procedures to collect tissue samples, which are then analyzed to make a diagnosis, rather than the device itself being diagnostic.
No
The device description explicitly details physical components like a needle guide, biopsy needle, anesthesia needle, and latex probe cover, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a biopsy kit used for collecting tissue samples from the prostate using ultrasound guidance. It is a tool for the procedure of obtaining a sample, not for analyzing the sample itself.
- Intended Use: The intended use clearly states it is for "performing planned and targeted ultrasound guided transrectal biopsies of the prostate." This describes a surgical or procedural action, not an in vitro test.
- Device Description: The description details the components used in the biopsy procedure (needle guide, biopsy needle, anesthesia needle, probe cover). It does not mention any reagents, assays, or analytical components typically found in IVDs.
The device is a medical device used for a diagnostic procedure (biopsy), but the diagnostic testing itself would be performed on the collected tissue sample separately in a laboratory, which would likely involve IVD methods.
N/A
Intended Use / Indications for Use
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound system.
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.
Product codes
90 ITX, 78 FCG
Device Description
The sterile TargetScan™ biopsy kit is designed to be used with the Targetscan™ Transrectal Ultrasound system. This kit includes a needle guide containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. This needle guide is the subject of a separate submission. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan™ transrectal probe Model #TS-360-P, which is the subject of a separate submission.
An anesthesia administration needle which can negotiate the curved needle guide and a latex probe cover are included in the kit as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Prostate
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Medical professionals in a physician office or hospital environment.
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 Biopsy needle advances 22mm during actuation of both the predicate and subject device. The needle is designed to allow the tip to protrude up to 2cm from the biopsy guide prior to firing the biopsy gun. Therefore the needle can be advanced as much 42mm beyond the disposable guide needle exit hole.
The subject needle was tested against the predicate needle in a bench test using calves' liver. In that test, they achieved comparable sample size lengths and weights.
Key Metrics
Not Found
Predicate Device(s)
Manan Biopsy needle (Medical Device Technology K980122), EP Deflectable Catheter, (EP Medsystems K033963)
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
K041638
as
a Biopsy
SEP - 2 2004
Section 3
510(k) Summary
| 1. Applicant: | Envisioneering, LLC
1982 Innerbelt Business Center Drive
St. Louis, MO 63114 |
|-------------------------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Tom Kappel |
| Telephone: | 314-429-7367 |
| FAX: | 314-429-7701 |
| 2. Date Prepared: | March 22, 2004 |
| 3. Trade Name: | TargetScan™ Biopsy kit |
| 4. Common Name: | Biopsy kit |
| 5. Establishment Registration Number: | pending |
| 6. Establishment Address: | Envisioneering, LLC
1982 Innerbelt Business Center Drive
St. Louis, MO 63114 |
| 7. Classification of the Device: | This device is classified
Instrument, as defined in CFR 876.1075, a Class II device. |
| 8. Identification of Predicate Device(s): | |
- Manan Biopsy needle (Medical Device Technology K980122) .
- EP Deflectable Catheter, (EP Medsystems K033963) .
Device Description: ഴ്.
ഗ്
The sterile TargetScan™ biopsy kit is designed to be used with the Targetscan™ Transrectal Ultrasound system. This kit includes a needle guide containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. This needle guide is the subject of a separate submission. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan™ transrectal probe Model #TS-360-P, which is the subject of a separate submission.
An anesthesia administration needle which can negotiate the curved needle guide and a latex probe cover are included in the kit as well.
1
10. Intended Use
Purpose and Function of the Device
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound system.
Intended Patient Population
This system is intended to be used with adult patients.
Intended Environment of Use
This system is intended for use by medical professionals in a physician office or hospital environment.
11. Technological Characteristics compared to those of the Predicate Devices
The components in the Biopsy kit are provided sterile, as are the various predicates.
The subject and predicate device (biopsy needle) are both intended to perform biopsies of the prostate gland. They are both intended to be used with the same reusable biopsy gun. The predicate device is manufactured of a stainless steel stylet and cannula. The subject device has a nitinol stylet and a polyolefin cannula. The use of this design and these materials allows the biopsy needle to negotiate the curved biopsy guide required to take the biopsy. The performance of these devices is equivalent in bench testing.
The predicate catheter is manufactured using the same polyolefin material as the cannula of the subject device.
12. Non-Clinical Performance Data
The Biopsy needle advances 22mm during actuation of both the predicate and subject device. The needle is designed to allow the tip to protrude up to 2cm from the biopsy quide prior to firing the biopsy gun. Therefore the needle can be advanced as much 42mm beyond the disposable guide needle exit hole.
The subject needle was tested against the predicate needle in a bench test using calves' liver. In that test, they achieved comparable sample size lengths and weights.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight. The symbol is composed of three curved lines that create a sense of movement and flow.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2004
Envisioneering, LLC % Ms. Chantel Carson Section Manager Underwriter Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062, USA
Re: K041638
Trade/Device Name: TargetScan Biopsy Kit Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 90 ITX and 78 FCG Dated: August 19, 2004 Received: August 23, 2004
Dear Ms. Carson:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.
3
. 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 (21 CFR Part 807); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter.
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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) you may obtain. Other general information on your responsibilities under the ACT may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon 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): __K041638 Device Name: TargetScan Biopsy Kit
Indications for Use:
This device is indicated for performing planned and targeted ultrasound guided transrectal many I his device is indicated for performing plantive and with the Envisioneering TargetScan model TS-360-P probe.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
OR