(119 days)
No
The summary describes a mechanical biopsy device and its accessories, with no mention of software, algorithms, or any features indicative of AI/ML. The performance studies are bench testing and biocompatibility, not related to algorithmic performance.
No.
The device is described as a biopsy system used for obtaining tissue samples for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is used to obtain biopsies from soft tissues, which are then analyzed to diagnose medical conditions. Obtaining a biopsy is a procedure specifically for diagnostic purposes.
No
The device description clearly indicates it is a physical biopsy system with needles and a protective sheath, not a software-only product.
Based on the provided information, the Temno Elite Biopsy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to obtain biopsy samples from soft tissues. It is a tool for collecting biological material from within the body.
- Device Description: The description details a physical device (needles, system) used for the mechanical process of taking a biopsy.
- Lack of In Vitro Testing: The description does not mention any components or processes related to testing or analyzing the collected sample outside of the body (in vitro). IVD devices are specifically designed for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Performance Studies: The performance studies focus on the physical characteristics and safety of the device itself (dimensional verification, tensile strength, biocompatibility), not on the analysis or interpretation of biological samples.
The Temno Elite Biopsy System is a surgical or procedural device used to collect samples for subsequent in vitro diagnostic testing, but it is not the IVD device itself. The collected tissue sample would then be sent to a laboratory for analysis using IVD methods.
N/A
Intended Use / Indications for Use
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney,breast,prostate, spleen,lung,lymph nodes,thyroid,and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney,prostate,spleen, lung,lymph nodes,thyroid, and various soft tissue masses. It is NOT intended for use in bone.
Product codes
KNW
Device Description
The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. The device has printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, and blue=12G. The needles have a protective sheath.
The Temno Elite Biopsy system includes Biopsy device and has the option of including a Valved Coaxial Introducer Needle, or a Standard Coaxial Introducer Needle. The depth stop on both the Valved Coaxial Introducer Needle and the Standard Coaxial Introducer Needle is color coded to match the gauge size of the Temno Elite Biopsy system.
The Temno Elite Biopsy System is supplies sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney,breast,prostate, spleen,lung,lymph nodes,thyroid,and various soft tissue masses.
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)
Performance testing was conducted based on the risk analysis and based on the requirements of the following documents:
- ANSI/AAMI/ISO 11135:2014 , Sterilization of health care products - routine control of a sterilization process for medical devices
- ISO 10993-7: 2008, Biological evaluation of medical devices Part 7: Ethylene oxide residuals
- ISO 7864: 2016, Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 6009:2016, Hypodermic needles for single use - Color coding for identification
- ISO 2233:2000, Complete, filled transport packages and unit loads - Conditioning for testing
- ISO 80369-7:2019, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging svstems
- ISO 11607-2:2019, Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980:2016, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
- ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010, Biological evaluation of medical devices – Part10: Tests for irritation and skin sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- United States Pharmacopeia 42, National Formulary 37 (USP) Pyrogen Test, 2019
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing- Bench
- Dimensional Verification
- Tensile of Joints
- Adjustable Throw Accuracy
- Multiple Samples
- Device Visibility
- Simulated Use
Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process," (2016), and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," (2018) as recognized by FDA. The battery of testing included the following test:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
The result of biocompatibility testing demonstrate that the subject device Temno Elite Biopsy System is considered biocompatible for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 28, 2020
Merit Medical Systems, Inc. Niloufar Samimi Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K201166
Trade/Device Name: Temno Elite Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: July 30, 2020 Received: August 3, 2020
Dear Niloufar Samimi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel G. Walter, Jr. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201166
Device Name Temno Elite Biopsy System
Indications for Use (Describe)
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney,breast,prostate, spleen,lung,lymph nodes,thyroid,and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney,prostate,spleen, lung,lymph nodes,thyroid, and various soft tissue masses. It is NOT intended for use in bone.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Temno Elite Biopsy System Premarket Notification 510(k)
5.0 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4583
Niloufar Samimi
26 April 2020
1721504 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Temno Elite Biopsy System
Biopsy System
Instrument, Biopsy
II
KNW
876.1075
Gastroenterology/ Urology |
| Predicate
Device | Premarket Notification Predicate #1:
Trade Name:
Classification Name:
Premarket Notification: | Bard® Mission® Disposable Core Biopsy
Instrument, Biopsy
K171953 |
| | Manufacturer: | Bard Peripheral Vascular, Inc |
| Predicate
Device | Premarket Notification Predicate #2:
Trade Name: | Achieve Programmable Automatic Biopsy
Systems |
| | Classification Name:
Premarket Notification:
Manufacturer: | Instrument, Biopsy
K141552
CareFusion |
| | These predicates have not been subject to a design-related recall. | |
| Device
Description | The subject device is a single use full core biopsy device. It is available
in several gauge sizes and lengths. The device has printed gauge size
indicator that is color coded according to the various gauge sizes (
yellow= 20G, pink= 18G, purple= 16 G, green= 14G, and blue=12G.
The needles have a protective sheath. | |
| | The Temno Elite Biopsy system includes Biopsy device and has the
option of including a Valved Coaxial Introducer Needle, or a Standard
Coaxial Introducer Needle. The depth stop on both the Valved Coaxial | |
4
Introducer Needle and the Standard Coaxial Introducer Needle is color coded to match the gauge size of the Temno Elite Biopsy system.
The Temno Elite Biopsy System is supplies sterile and is intended for single use only.
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy Indications for samples from soft tissue such as liver, kidney, prostate, spleen, lung, Use lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone.
There is no change in the Indications for Use Statement from the predicate to the subject device.
The technological characteristics of the subject Temno Elite Biopsy System device are substantially equivalent to those of the predicate device #1 Bard® Mission® Disposable Core Biopsy and Reference Predicate Device #2, Achieve Programmable Automatic Biopsy.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Clinical use
- Labeling ●
- Basic design ●
Comparison to Predicate Device
- Principle of operation ●
- Performance ●
- Soft tissues ●
- Adjustable throw lengths ●
The following technological differences exist between the subject and predicate devices:
- Needle gauges
- Materials .
- Biopsy chamber geometry
- Sample eject assist ●
5
FDA guidance and recognized performance standards have been established for Biopsv instrument under Section 514 of the Food. Drug and Cosmetic Act. A battery of tests was performed based on the requirements of the below recognized performance standards and quidance, as well as biocompatibility, sterilization, and labeling standards and quidance. Conformity to these standards demonstrates that the proposed Temno Elite Biopsy System met the standards' established acceptance criteria applicable to the safety and efficacy of the device. Performance testing was conducted based on the risk analysis and based on the requirements of the following documents:
- ANSI/AAMI/ISO 11135:2014 , Sterilization of health care products -● routine control of a sterilization process for medical devices
- ISO 10993-7: 2008, Biological evaluation of medical devices Part 7: ● Ethylene oxide residuals
- ISO 7864: 2016, Sterile hypodermic needles for single use -● Requirements and test methods
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 6009:2016, Hypodermic needles for single use - Color coding for identification
- ISO 2233:2000, Complete, filled transport packages and unit loads -● Conditioning for testing
- ISO 80369-7:2019, Small-bore connectors for liquids and gases in ● healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Performance Data
- . ISO 11607-1:2019, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging svstems
- . ISO 11607-2:2019, Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
- . ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980:2016, Standard Guide for Accelerated Aging of Sterile ● Barrier Systems for Medical Devices
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing within a risk management process
- . ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010, Biological evaluation of medical devices – Part10: Tests for irritation and skin sensitization
- . ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- United States Pharmacopeia 42, National Formulary 37 (USP) Pyrogen Test, 2019
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing- Bench
6
- Dimensional Verification ●
- Tensile of Joints ●
- Adjustable Throw Accuracy
- Multiple Samples ●
- Device Visibility ●
- Simulated Use ●
Biocompatibility testing
The biocompatibility evaluation for the Temno Elite Biopsy System was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process," (2016), and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," (2018) as recognized by FDA. The battery of testing included the following test:
- Cytotoxicity
- Sensitization ●
- Irritation
- Acute Systemic Toxicity ●
- . Pyrogenicity
The result of biocompatibility testing demonstrate that the subject device Temno Elite Biopsy System is considered biocompatible for its intended use.
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing, the subject Temno Elite Biopsy System meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate device #1 Bard Mission Disposable Core Biopsy Instrument, K171953 and Reference Predicate device #2 Achieve Programmable Automatic Biopsy, K141552.