(274 days)
Not Found
No
The description details a mechanical biopsy instrument and needle, with no mention of software, algorithms, or any form of AI/ML processing. The performance studies focus on physical and material properties.
No.
The device is used to obtain tissue samples, which is a diagnostic procedure, not a therapeutic one.
Yes
Explanation: The device is used to obtain samples from soft tissue to diagnose various conditions. Obtaining tissue samples for analysis falls under the umbrella of diagnostic procedures.
No
The device description clearly details a physical, mechanical instrument with a needle, handle, and adjustable components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain samples from soft tissue". This is a procedure to collect a sample from the body.
- Device Description: The description details a mechanical instrument used for physically extracting tissue.
- Lack of In Vitro Activity: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device's function is solely to acquire the sample.
The device is a tool for obtaining a sample that could then be used in an in vitro diagnostic test, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other masses.
Product codes
KNW
Device Description
The Semi-Automatic Biopsy Instrument is used to obtain soft tissue biopsies. It is composed of a spring-loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The position of the needle may be visualized by x-ray, CT, or ultrasound.
The needle has numerically ordered centimeter markings to facilitate precise depth placement. The adjustable instrument allows for a specimen notch size of 10mm or 20mm, providing clinical flexibility. The device has an adjustable co-axial adapter built into the device for either the 10mm or 20mm notch settings. The stylet travels up to 27mm from when the device is in a fully charged position (prepared for a collection with the 20 mm notch size) to when the stylet is fully extended. The needle has an echogenic tip. The semi-automatic biopsy instrument is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g., green=14-gauge, purple=16-gauge, pink=18-gauge, and yellow=20-gauge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, CT, or ultrasound.
Anatomical Site
soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other 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 Tests (Non-Clinical) were conducted:
- Dimensional
- Peak Tensile Strength
- Simulated Use (Charging Force, Firing Force, Minimum Firing Force, Dry Firing, Sample Collection)
- Shipping Qualification (Product and Packaging Integrity)
- Radiopacity
- Echogenicity
- Corrosion Resistance
- Resistance to Breakage / Needle Bending
- Accelerated and Real-Time Aging
- Penetration Force
- Tissue Sampling
Biocompatibility Testing was conducted:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation or Intracutaneous Reactivity (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogenicity (ISO 10993-11)
The testing was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974814 Argon Medical SuperCore™ Biopsy Instrument
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows 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" in blue, and the word "ADMINISTRATION" in a smaller font size below.
July 1, 2022
Argon Medical Devices Daniel Lanois Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens. Texas 75751
Re: K213232
Trade/Device Name: Semi-Automatic Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 15, 2022 Received: June 16, 2022
Dear Daniel Lanois:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 medical devices and radiation-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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213232
Device Name Semi-Automatic Biopsy Intrument
Indications for Use (Describe)
The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other masses.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Date Prepared: | June 30, 2022 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Scott Bishop |
| Director Regulatory Affairs | |
| Phone: 469-731-1413 | |
| Fax: 903-677-9396 | |
| Email: scott.bishop@argonmedical.com | |
| Device Trade Name | |
| (Subject Device): | Semi-Automatic Biopsy Instrument |
| Device Common | |
| Name: | Biopsy Instrument |
| Device Classification: | Instrument, Biopsy |
| Product code: KNW | |
| 21 CFR 876.1075 | |
| Class II | |
| Review Panel: Gastroenterology/Urology | |
| Predicate Device(s): | K974814 Argon Medical SuperCore™ Biopsy Instrument |
| Description of the | |
| Device: | The Semi-Automatic Biopsy Instrument is used to obtain soft |
| tissue biopsies. It is composed of a spring-loaded biopsy | |
| needle fitted into a plastic handle permitting single handed | |
| specimen collection. The position of the needle may be | |
| visualized by x-ray, CT, or ultrasound. |
The needle has numerically ordered centimeter markings to
facilitate precise depth placement. The adjustable instrument
allows for a specimen notch size of 10mm or 20mm, providing
clinical flexibility. The device has an adjustable co-axial
adapter built into the device for either the 10mm or 20mm
notch settings. The stylet travels up to 27mm from when the
device is in a fully charged position (prepared for a collection
with the 20 mm notch size) to when the stylet is fully extended.
The needle has an echogenic tip. The semi-automatic biopsy
instrument is available in several needle gauge sizes and |
510(k) Summary
4
| K213232 | |||
|---|---|---|---|
| lengths. The plunger is color coded according to the various | |||
| gauge sizes, e.g., green=14-gauge, purple=16-gauge, | |||
| pink=18-gauge, and yellow=20-gauge. | |||
| Indication for Use: | The Semi-Automatic Biopsy Instrument and associated Co- | ||
| Axial Introducer Needle are used to obtain samples from soft | |||
| tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, | |||
| breast, thyroid, pancreas, and other masses. | |||
| Technological | |||
| Characteristics: | A comparison of the technological characteristics of the | ||
| Subject device and the Predicate device demonstrates the | |||
| Subject device to be substantially equivalent to the current | |||
| marketed Predicate device. | |||
| The Subject device and the Predicate device are based on the | |||
| following same technological elements: | |||
| ● Use of an adjustable specimen notch size | |||
| ● Use of a semi-automatic spring-loaded biopsy needle | |||
| permitting the stylet to advance prior to firing the | |||
| cannula | |||
| ● Use of an echogenic needle tip | |||
| ● Numerically ordered centimeter markings to facilitate | |||
| precise depth placement of the needle | |||
| The following technological differences exist between the | |||
| Subject device and the Predicate device: | |||
| ● Use of a co-axial adapter built into the Subject Device | |||
| and is not built into the Predicate Device. | |||
| SUBJECT DEVICE | PREDICATE DEVICE | ||
| Semi-Automatic | |||
| Biopsy Instrument | SuperCore™ Biopsy | ||
| Instrument | |||
| Manufacturer | Argon Medical Devices, | ||
| Inc - TX | SAME | ||
| Gauge Size | 14ga, 16ga, 18ga, 20ga | 14ga, 16ga, 18ga, | |
| 20ga | |||
| Lengths | 6cm, 10cm, 16cm, | ||
| 20cm, 25cm (18ga only) | 6cm, 9cm, 15cm, | ||
| 20cm | |||
| Notch Size | 10mm and 20mm | 9.5mm and 19mm | |
| Tip Geometry | |||
| (Stylet and | |||
| Cannula) | Bevel | SAME | |
| Echogenicity | |||
| (Tip) | Yes | SAME | |
| Needle | |||
| Manufacturer | Argon Medical Devices, | ||
| Inc. - IL | SAME | ||
| Patient | |||
| Contacting | |||
| Materials | Stylet: 304 SS | ||
| Cannula: 304 SS | SAME | ||
| Function Type | Semi-Automatic | SAME | |
| Disposable | Yes | SAME | |
| Performance | |||
| Testing | • Dimensional | ||
| • Peak Tensile Strength | |||
| • Simulated Use | |||
| (Charging Force, | |||
| Firing Force, Minimum | |||
| Firing Force, Dry | |||
| Firing, Sample | |||
| Collection) | |||
| • Shipping Qualification | |||
| (Product and | |||
| Packaging Integrity) | |||
| • Radiopacity | |||
| • Echogenicity | |||
| • Corrosion Resistance | |||
| • Resistance to | |||
| Breakage / Needle | |||
| Bending | |||
| • Accelerated and Real- | |||
| Time Aging | |||
| • Penetration Force | |||
| • Tissue Sampling | • Dimensional | ||
| • Peak Tensile | |||
| Strength | |||
| • Durability of | |||
| Instrument | |||
| • Charging Force | |||
| • Firing Force | |||
| • Dry Firing (minimum | |||
| firing force) | |||
| • Sample Collection | |||
| • Shipping | |||
| Qualification | |||
| Biological | |||
| Comparison | Complies to ISO 10993- | ||
| 1:2018 | |||
| • Cytotoxicity (ISO | |||
| 10993-5) | |||
| • Sensitization (ISO | |||
| 10993-10) | |||
| • Irritation or - | |||
| Intracutaneous | |||
| Reactivity (ISO 10993- |
• Acute Systemic
Toxicity (ISO 10993-
11)
• Material Mediated
Pyrogenicity (ISO
10993-11) | Complies to ISO
10993-1:2009
• Cytotoxicity (ISO
10993-5)
• Sensitization (ISO
10993-10)
• Irritation -
Intracutaneous
Reactivity (ISO
10993-10) | |
| Intended
Shelf-Life | 6 months | 5 years | |
| Packaging /
Shipping | Biopsy Instrument
Only | Biopsy Instrument
Only | |
17mm, 27mm
12mm, 22mm
Throw
5
6
| • One biopsy device
packaged in a Tyvek
Pouch | • One biopsy device
packaged in a Tyvek
Pouch |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Co-packaged Kit
• One biopsy device,
corresponding coaxial
introducer needle in a
holder packaged in a
Tyvek pouch (18ga
and 20ga coaxial
introducer needles are
provided with an
additional blunt stylet)
10 pouches and one IFU
in each labeled shipping
carton | Co-packaged Kit
• One biopsy device
with corresponding
coaxial introducer
needle, and adaptor
packaged in a Tyvek
pouch
10 pouches and one
IFU in one labeled shelf
carton |
Equivalence is based upon the product performance, design and intended use. The Subject device and the Predicate device have similar materials of construction, dimensional specifications, design, and sterilization process. This demonstrates that the Subiect device is as safe and effective as the Predicate device, and it does not raise different questions of safety and effectiveness than the Predicate device.
Performance Tests No performance standards have been established under (Non-Clinical): section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the testing below was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence.
The following tests were performed under the specified testing parameters to support the Subject device substantial equivalence.
Performance Testing, including:
- Dimensional ●
- Peak Tensile Strength
- Simulated Use (Charging Force, Firing Force, Minimum ● Firing Force, Dry Firing, Sample Collection)
- Shipping Qualification (Product and Packaging Integrity) ●
- Radiopacity
- Echogenicity ●
7
- Corrosion Resistance ●
- Resistance to Breakage / Needle Bending ●
- Accelerated and Real-Time Aging ●
- Penetration Force ●
- Tissue Sampling o
Biocompatibility Testing, including:
- Cytotoxicity (ISO 10993-5) .
- Sensitization (ISO 10993-10) ●
- Irritation or Intracutaneous Reactivity (ISO 10993-10) ●
- . Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogenicity (ISO 10993-11) ●
| Substantial
Equivalence: | Based on the Indication for Use, design, and safety and
performance testing, the Subject device meets the
requirements for its intended use and is substantially
equivalent to the Predicate device. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The results of all testing demonstrate that the Subject device is
substantially equivalent to the Predicate device. |