(29 days)
Not Found
No
The document describes a mechanical biopsy system and does not mention any AI or ML components.
No
The "Intended Use / Indications for Use" section explicitly states, "This instrument is for diagnostic use only and is not indicated for therapeutic use."
Yes
The "Intended Use / Indications for Use" section explicitly states, "This instrument is for diagnostic use only." It is used to obtain tissue samples for "diagnostic analysis."
No
The device description clearly states it is an automated core needle biopsy system that includes a probe needle with a spring-loaded inner piercing stylet and outer cutting cannula. This indicates it is a physical medical device, not software only.
Based on the provided information, the Mammotome AutoCore™ Single Insertion Core Biopsy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis. The Mammotome AutoCore™ is a device used to obtain the tissue sample from the body.
- The intended use clearly states it is used to "obtain tissue samples... for diagnostic analysis". The diagnostic analysis itself would be performed on the tissue sample, likely in a laboratory setting using other IVD devices or procedures.
- The device description focuses on the mechanism of obtaining the sample (needle, stylet, cannula). It doesn't describe any components or processes for analyzing the tissue itself.
In summary, the Mammotome AutoCore™ is a biopsy device used to collect a sample, which is then sent for diagnostic analysis, potentially using IVD methods. The device itself is not performing the in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use. The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast or lymph nodes
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- Bench: Functional testing was performed for comparison of static force to penetrate, lesion displacement, overmold bond strength and bend load to prove substantial equivalence.
Performance- Animal: Animal testing was performed to verify appropriate sample weight, acquisition, and quality.
Software: IEC 62304 Edition 1.1 2015-06 Medical Device Software
Electrical: IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance.
Biocompatibility: ISO 10993-1:2018-Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
Biocompatibility- Cytotoxicity: ISO 10993-5:2009-Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
Biocompatibility- Sensitization: ISO 10993-10:2010-Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
Biocompatibility- Pyrogenicity/Acute System Toxicity: ISO 10993-11:2017-Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
Biocompatibility- Irritation/Intracutaneous Reactivity: ISO 10993-23:2021 Biological Evaluation of Medical Devices – Part 23: Tests for Irritation
N/A - Clinical testing was not required for subject device
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
October 29, 2024
Devicor Medical Products, Inc. % Prithul Bom Most Responsible person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K243095
Trade/Device Name: Mammotome AutoCore™ Single Insertion Core Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: September 27, 2024 Received: September 30, 2024
Dear Prithul Bom:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Jessica Carr -S
Jessica Carr, 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Mammotome AutoCore™ Single Insertion Core Biopsy System
Indications for Use (Describe)
The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use.
The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.
Type of Use (Select one or both, as applicable)
scription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 510(k) SUMMARY | ||
|---|---|---|
| A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92. | ||
| SUBMITTER INFORMATION | ||
| Name | Devicor Medical Products, Inc. | |
| Address | 300 E. Business Way, Fifth Floor, Cincinnati, OH 45241 | |
| U.S.A | ||
| Establishment Registration | ||
| Number | 3008492462 | |
| Name of contact person | Jamie Edenborg | |
| Date prepared | 23-JUL-2024 | |
| PRODUCT | ||
| Mammotome AutoCore™ Single Insertion Core Biopsy System | ||
| PRODUCT COMPONENTS | ||
| PRODUCT | DESCRIPTION | |
| Mammotome AutoCore® Holster and Charging | ||
| Base | Holster and Charging Base | |
| Mammotome AutoCore® Probe 12 Gauge | Probe 12g x 10cm | |
| Mammotome AutoCore® Probe 14 Gauge | Probe 14g x 10cm | |
| Mammotome AutoCore® Introducer 12 Gauge | Introducer 12g x 10cm | |
| Mammotome AutoCore® Introducer 14 Gauge | Introducer 14g x 10cm | |
| DESCRIPTION OF DEVICE | ||
| Trade or proprietary name | Mammotome AutoCore™ Single Insertion Core | |
| Biopsy System | ||
| Common or usual name | Core Biopsy System, Single Insertion | |
| Classification name | Instrument, biopsy | |
| Classification panel | Gastroenterology/Urology | |
| Regulation | 21 CFR §876.1075 | |
| Product code(s) | KNW | |
| Legally marketed device(s) to which | ||
| equivalence is claimed | K141552 Achieve® Programmable Automatic | |
| Biopsy System | ||
| Submission Type | Traditional 510(k) Premarket Notification | |
| Device description | The Mammotome AutoCore™ Single Insertion | |
| Core Biopsy System is an automated core | ||
| needle biopsy system. It is a single insertion, | ||
| multiple sample device that includes | ||
| automated arming and automated sample | ||
| collection. It is available in two gauge sizes | ||
| (12G and 14G) and acquires soft tissue | ||
| samples using a spring-loaded inner piercing | ||
| stylet and outer cutting cannula in the probe | ||
| needle. | ||
| Intended use of the device | The Mammotome AutoCore™ Single Insertion | |
| Core Biopsy System is intended to obtain | ||
| tissue samples from the breast or lymph nodes | ||
| for diagnostic analysis of breast abnormalities |
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This instrument is for diagnostic use only and is not indicated for therapeutic use. The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate |
|---|---|---|
| Mode of Action | Single Puncture and Multiple | |
| Samples | Single Puncture and Multiple | |
| Samples | ||
| Firing Modes | Automatic | Automatic and Delay |
| Anatomical Sites | Breast tissue and lymph | |
| nodes | Breast tissue, lymph nodes, | |
| kidney, liver, prostate, spleen | ||
| and various soft tissue | ||
| masses |
CONCLUSION OF DEVICE COMPARISON
A comparison of the technological characteristics of the proposed device and predicate device supports a determination of substantial equivalence.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE Performance Test Summary
| Characteristic | Standard/Test/FDA Guidance |
|---|---|
| Performance- Bench | Functional testing was performed for |
| comparison of static force to penetrate, lesion | |
| displacement, overmold bond strength and | |
| bend load to prove substantial equivalence. | |
| Performance- Animal | Animal testing was performed to verify |
| appropriate sample weight, acquisition, and | |
| quality. | |
| Software and Electrical Test Summaries | |
| Characteristic | Standard/Test/FDA Guidance |
6
| Software | IEC 62304 Edition 1.1 2015-06 Medical Device
Software |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical | IEC 60601-1-6 Edition 3.1 2013-10 Medical
electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance. |
| Biocompatibility Data | |
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | ISO 10993-1:2018-Biological Evaluation of
Medical Devices - Part 1: Evaluation and
Testing Within a Risk Management Process |
| Biocompatibility- Cytotoxicity | ISO 10993-5:2009-Biological Evaluation of
Medical Devices – Part 5: Tests for In Vitro
Cytotoxicity |
| Biocompatibility- Sensitization | ISO 10993-10:2010-Biological Evaluation of
Medical Devices – Part 10: Tests for Irritation
and Skin Sensitization |
| Biocompatibility- Pyrogenicity/Acute System
Toxicity | ISO 10993-11:2017-Biological Evaluation of
Medical Devices - Part 11: Tests for Systemic
Toxicity |
| Biocompatibility- Irritation/Intracutaneous
Reactivity | ISO 10993-23:2021 Biological Evaluation of
Medical Devices – Part 23: Tests for Irritation |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION [Per 807.92(b)(1)(2)(3)] | |
| N/A - Clinical testing was not required for subject device | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
The verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, and materials of construction, supports a determination that the Devicor Medical Products, Inc. Mammotome AutoCore™ Single Insertion Core Biopsy System [subject device] is substantially equivalent to the Achieve® Programmable Automatic Biopsy System (K141552) [predicate device].