(30 days)
Not Found
Not Found
No
The description focuses on the mechanical action of the device (spring-activated stylet and cannula) and does not mention any computational or data-driven processes characteristic of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is used for tissue sampling for diagnostic purposes, not for treating a disease or condition.
No
The device is used to collect tissue samples for microscopic evaluation, which is a step in the diagnostic process, but the device itself does not perform the diagnosis.
No
The device description clearly states it is an "automated device comprised of a spring that activates a stylet and cannula," which are physical hardware components used for tissue cutting and trapping.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information about a physiological state, health, or disease. This is typically done in vitro (outside the body) using tests on blood, urine, tissue samples, etc.
- This device is used to obtain the tissue sample. It's a tool for collecting the specimen, not for analyzing it. The analysis (microscopic evaluation) happens after the tissue is collected, and that analysis would likely involve IVD procedures or devices, but the biopsy device itself is not an IVD.
The description clearly states its purpose is for "tissue sampling" and to "remove, by cutting, a specimen of tissue for microscopic evaluation." This is a procedure to acquire the sample, not to perform a diagnostic test on it.
N/A
Intended Use / Indications for Use
The Disposable Semi-Automated Temno® Biopsy Device is a system used for tissue sampling from several different organs, including, but not limited to, the Kidney, Liver, Breast and Prostate.
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
Product codes (comma separated list FDA assigned to the subject device)
78 FCG
Device Description
Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Kidney, Liver, Breast and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the manufacturing of the Disposable Semi-Automated Temno® Biopsy Device have been evaluated as outlined in the ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The materials were found to be acceptable for this intended use.
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.
Temno® Biopsy Device
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.
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Image /page/0/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. Below the word "Allegiance" is the text "a Cardinal Health company" in a smaller, non-italicized font.
K 024/20
Pg 1 of 2
JAN 1 5 2003
Biopsy Device
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Disposable Semi-Automated Temno® Biopsy Device
Sponsor:
Allegiance Healthcare Corporation, 1500 Waukegan Road MPWM McGaw Park, IL 60085
| Regulatory Affairs Contact: | Sharon Nichols |
|---|---|
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | December 2002 |
| Product Trade Name: | Disposable Semi-Automated Temno® |
- Disposable Biopsy System Common Name:
- Class II per 21 CFR §876.1075, Instrument, Biopsy Classification:
Disposable Semi-Automated Temno® Biopsy Device
Description:
Predicate Device:
Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.
1
Image /page/1/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The word "Allegiance" is written in a stylized font, with a cross-shaped symbol made of dots to the left of the word. Below the word "Allegiance" is the text "a Cardinal Health company" in a smaller font.
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads 'K 024 120'. Below that, the text reads 'pg 2 of 2'.
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Disposable Semi-Automated Temno® Biopsy Device
| Intended Use: | The Disposable Semi-Automated Temno® Biopsy Device
is a system used for tissue sampling from several
different organs, including, but not limited to, the
Kidney, Liver, Breast and Prostate. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Disposable Semi-Automated Temno® Biopsy Device is
substantially equivalent to the Temno® Biopsy Device in
that:
- Intended use is the same
- Performance attributes are the same |
| Summary of testing: | All materials used in the manufacturing of the Disposable
Semi-Automated Temno® Biopsy Device have been
evaluated as outlined in the ISO 10993, "Biological Evaluation
of Medical Devices Part 1: Evaluation and Testing". The
materials were found to be acceptable for this intended use. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2003
Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare 1500 Waukegan Road MCGAW PARK IL 60085
Re: K024120
Trade/Device Name: Temno® Biopsy Needle Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: December 13, 2002 Received: December 16, 2002
Dear Ms. Nichols:
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 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. 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.
3
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 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" (21CFR Part 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 C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The word "Allegiance" is written in a bold, sans-serif font, with a stylized cross symbol to the left of the word. Below the word "Allegiance" is the text "a Cardinal Health company" in a smaller font. The logo is simple and professional, and it clearly identifies the company as being part of the Cardinal Health organization.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
K 024120
Device Name:
Biopsy Semi-Automated Temno® Disposable Device
Indications For Use:
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
(Please Do NOT WRITE BELOW THIS LINE - Continue ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
or
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Daniel A. Symm
29
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devic 510(k) Number