(17 days)
No
The summary describes a physical biopsy kit and needle guide designed for use with an ultrasound system, but there is no mention of software, algorithms, or any AI/ML related terms.
No.
The device is used for performing biopsies, which is a diagnostic procedure to obtain tissue samples, not to treat a condition.
No
The device is a biopsy kit, which is used to collect tissue samples. While these samples are then used for diagnostic purposes, the kit itself is a tool for sample collection, not for diagnosis.
No
The device description explicitly details physical components like a biopsy needle, needle guide, and biopsy attachment, indicating it is a hardware-based medical device kit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The TargetScan Biopsy Kit is a device used to obtain a tissue sample (biopsy) from the prostate. It is a tool for the collection of the specimen, not for the examination or analysis of the specimen itself.
- Intended Use: The intended use clearly states it's for "performing planned and targeted ultrasound guided transrectal biopsies of the prostate." This describes a procedure to collect a sample, not to perform a diagnostic test on a sample.
While the collected tissue sample will likely be sent to a lab for in vitro diagnostic testing (like histology), the TargetScan Biopsy Kit itself is a device used in the in vivo procedure of obtaining that sample.
N/A
Intended Use / Indications for Use
The TargetScan Biopsy Kit intended use is 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® Ultrasound system.
Product codes (comma separated list FDA assigned to the subject device)
FCG, ITX
Device Description
The steries Targetsound system. This kit (K041638) includes The Biopsy Needle and the needle guide (K041637) containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. 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 (K041639) an anesthesia administration needle and a latex probe cover that were included in the original 510(k) are now optional components of the kit and are currently not included. These items are still recommended and can be readily obtained from other sources.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guided
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Applicable testing was performed in accordance with approved Validation protocols and the Risk Analysis to ensure the product is properly manufactured, packaged and sterilized. The package and materials used meet the requirements of ISO 11607-1.
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.
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
TargetScan® Biopsy Kit and Biopsy Needle Special 510(k)
Envisioneering, L.L.C. November 26, 2007
Section 8 - 510(k) Summary
510(k) Summary
| Applicant: | Envisioneering, LLC
1982 Innerbelt Business Center Drive
St. Louis, MO 63114 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Kennedy |
| Telephone: | 314-429-7367 |
| FAX: | 314-429-7701 |
| Date Prepared: | November 26, 2007 |
| Trade Name: | TargetScan® Biopsy kit
TargetScan® Biopsy Needle Guide |
| Common Name: | Biopsy kit
Biopsy Needle Guide |
| Establishment Registration Number: | 3005673110 |
| Establishment Address: | Envisioneering, LLC
1982 Innerbelt Business Center Drive
St. Louis, MO 63114 |
| Classification of the Device: | The Biopsy Kit is classified as a Biopsy Instrument, as
defined in CFR 876.1075, Class II device. The Needle Guide
is a Class II, CFR 892.1570 |
| Product Code: | Biopsy Kit FCG
Needle Guide ITX |
Identification of Predicate Device(s):
Envisioneering TargetScan® Biopsy Kit 510(k) # K041638, originally cleared September 2, 2004.
Envisioneering TargetScan® Biopsy Needle Guide 510(k) # K041637, originally cleared September 1, 2004.
Device Description:
. .
Devree Deserription The steries Targetsound system. This kit (K041638) includes The Biopsy Needle and the needle guide (K041637) containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. 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 (K041639) an anesthesia administration needle and a latex probe cover that were included in the original 510(k) are now optional components of the kit and are currently not included. These items are still recommended and can be readily obtained from other sources.
1
Envisioneering, L.L.C. November 26, 2007
TargetScan® Biopsy Kit and Biopsy Needle Guide Special 510(k)
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.
Technological Characteristics compared to those of the Predicate Devices
The components in the Biopsy kit are provided sterile, as are the predicate device. Minor changes to the labeling layout and package dimensions were made. An alternate contract manufacturing and sterilization facility is being added to manufacture the kits for Envisioneering Medical. The materials and intended use remain unchanged from the original 510(k). The new manufacturing facility is an FDA registered facility and the quality management system is certified to ISO 13485.
The predicate device included a 1 year shelf life; this has been tested and extended to 3 years in the modified device.
The anesthesia needle and latex probe cover included in the original 510(k) are optional components that may not be included in the kits (Currently are not included). These items are readily available from other sources and are still recommended for use.
The End of the Needle Guide has a slightly different profile than the predicate device to aid insertion into the rectum.
The Modified TargetScan® Biopsy Kit and Guide use the same basic design, same sterility assurance level (SAL 10th) and method (Ethylene Oxide), the same scientific technology and has the same intended use as the originally cleared predicate devices.
Performance Data
Applicable testing was performed in accordance with approved Validation protocols and the Risk Analysis to ensure the product is properly manufactured, packaged and sterilized. The package and materials used meet the requirements of ISO 11607-1.
Conclusion:
The addition of an alternate manufacturing and sterilization facility does not change the fundamental scientific technology or the intended use of the device as compared to the predicate device. These modifications do not raise new questions regarding safety or effectiveness of the devices originally cleared on September 1, 2004 and September 2, 2004 under 510(k) K041637 and K041638 respectively.
The performance data and declaration of conformity with design controls support the determination of continuing substantial equivalence of the previously cleared and predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized symbol that resembles a human figure with outstretched arms, with three wavy lines above it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2007
Mr. David Kennedy
Director, Quality Assurance and Regulatory Affairs Envisioneering Medical Technologies 1982 Innerbelt Business Center Drive ST LOUIS MO 63114
Re: K073399
Trade/Device Name: TargetScan® Biopsy Needle Kit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG and ITX Dated: November 26, 2007 Received: December 4, 2007
Dear Mr. Kennedy:
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.
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.
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 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.
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 one of the following numbers, 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Envisioneering, L.L.C November 26, 2007
TargetScan® Biopsy Kit and Biopsy Needle Guide Special 510(k)
Attachment III
Indications for Use Statement
Biopsy Needle Kit
Originally cleared under K041638
| 510(k) Number | K073399 |
|---|---|
| Device Name | TargetScan Biopsy Needle Kit |
| Indications for Use | The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system. |
Prescription Use ✓
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K073399