(191 days)
Not Found
No
The provided text does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on mechanical aspects (pulses, probes, driver) and guidance via ultrasound, without indicating any AI/ML-driven analysis or decision-making.
No
The device is used for obtaining tissue samples for diagnostic analysis, not for treating a condition or disease.
No
Explanation: The device is used for obtaining tissue samples for diagnostic analysis and histologic examination, but it does not perform the diagnostic analysis itself. It is a biopsy system, a tool used in the process of diagnosis, rather than a diagnostic device that interprets data to provide a diagnosis.
No
The device description explicitly states the system is composed of a base unit, a driver, and two types of sterile single-use probes, indicating it includes hardware components beyond just software.
Based on the provided information, the NeoNavia biopsy system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to obtain tissue samples for diagnostic analysis. The device itself is a tool for sample collection, not for performing the diagnostic analysis on the sample.
- Device Description: The description focuses on the mechanical aspects of obtaining tissue samples using pulses and ultrasound guidance. It doesn't describe any components or processes for analyzing biological samples in vitro.
- Lack of IVD Characteristics: IVD devices typically involve reagents, calibrators, controls, or software designed to analyze biological samples (like blood, urine, tissue) outside of the body to provide diagnostic information. This device's function is limited to the physical act of acquiring the sample.
- Performance Studies: The performance studies described focus on the device's ability to obtain samples (sample quality, bleeding, hematoma), not on the accuracy or reliability of any diagnostic test performed on those samples.
The diagnostic analysis itself would be performed separately in a laboratory using other methods and potentially other IVD devices. The NeoNavia system is a crucial step in the diagnostic process, but it is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities.
The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination.
The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
NeoNavia® biopsy system is designed to obtain tissue samples from breast lesions or axillary lymph nodes for histological evaluation. The system is composed of a base unit, a driver and two different types of sterile single use probes. Each probe type (also referred to as needle) utilizes pulses with the intention to improve precision and control when inserting and positioning the biopsy needle in a suspicious lesion. NeoNavia® must be operated together with ultrasound imaging guidance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast lesions and axillary lymph nodes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals in hospitals or healthcare facilities.
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)
- Sterilization, Shelf Life and Packaging: sterilization validation, sterile packaging validation and shelf life testing have been performed for the sterile disposable probes.
- Biocompatibility Testing: Biocompatibility testing results for cytotoxicity, irritation, sensitization, acute systemic toxicity and materials mediated pyrogenicity indicate the NeoNavia VacuPulse probe is safe for its indicated use.
- Software and Security: The Level of Concern associated with the software of the NeoNavia Biopsy System is considered to be Moderate. Testing was completed in accordance with the guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Final, 2005).
- Electromagnetic Compatibility and Electrical Safety: Electromagnetic compatibility and electrical safety testing was performed on the NeoNavia Biopsy System.
- Bench Testing: Various bench testing was performed for verification of the NeoNavia Biopsy System. Testing included comparison performance testing, usability validation and performance verification testing.
- Animal Testing: Animal testing was conducted to compare the NeoNavia VacuPulse, NeoNavia Flexipulse and Mammotome biopsy devices. Biopsy samples from sheep and pigs were evaluated for biopsy sample quality (gross qualitative assessment and via histopathology), acute bleeding rate, and hematoma.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NeoDynamics AB % Leann Latham Regulatory Consultant M Squared Associates,Inc. 127 West 30th Street. 9th Floor New York, New York 10001
September 8, 2022
Re: K220595
Trade/Device Name: NeoNavia Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: August 1, 2022 Received: August 3, 2022
Dear Leann Latham:
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
1
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 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 (OS) 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,
Colin Chen Acting 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
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Indications for Use
510(k) Number (if known) K220595
Device Name NeoNavia Biopsy System
Indications for Use (Describe)
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities.
The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination.
The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.
| 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
Section 005: 510k Summary
The following information is provided as required by 21 CFR § 807.87 for NeoNavia Biopsy System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
- Sponsor: NeoDynamics AB Anna Forsberg Medical Affairs Manager and Country Manager, US Lejonvägen 14 181 32 Lidingö SWEDEN Phone: 973-953-9885 Email: anna.forsberg@neodynamics.com
- LeAnn Latham Contact: M Squared Associates, Inc. 127 West 30th Street New York, NY 10001 E-mail: llatham@msquaredassociates.com Phone: 347-954-9482 Fax (703) 562-9797
| Date of Submission: | February 28, 2022 |
|---|---|
| Proprietary Name: | NeoNavia Biopsy System |
| Common Name: | Instrument, Biopsy |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 876.1075 |
| Product Codes: | KNW, FCG |
| Predicate Devices: | Primary Device Trade Name: Mammotome elite® Biopsy System |
| Device Company: Devicor® Medical Products, Inc. | |
| 510(k) Number: K153709 |
Device Description :
NeoNavia® biopsy system is designed to obtain tissue samples from breast lesions or axillary lymph nodes for histological evaluation. The system is composed of a base unit, a driver and two different types of sterile single use probes. Each probe type (also referred to as needle) utilizes pulses with the intention to improve precision and control when inserting and positioning the biopsy needle in a suspicious lesion. NeoNavia® must be operated together with ultrasound imaging guidance.
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Intended Use
The NeoNavia biopsy system is intended for obtaining tissue samples from both breast lesions and axillary lymph nodes for diagnostic analysis of breast abnormalities.
Indications for Use:
The FlexiPulse and VacuPulse probes are intended to provide tissue from breast lesions and axillary lymph nodes for histologic examination.
The NeoNavia biopsy system is to be used only by healthcare professionals in hospitals or healthcare facilities.
Technological characteristics, comparison to predicate device:
| Table 1: Comparison table of NeoNavia and the predicates | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | -- | ---------------------------------------------------------- | -- | -- | -- | -- | -- | -- |
| Characteristics | NeoNavia® Biopsy | Mammotome elite® | Differences and |
|---|---|---|---|
| System (subject device) | Biopsy System | Comments | |
| (Primary predicate) | |||
| Description | NeoNavia® biopsy | ||
| system is designed to | |||
| obtain tissue samples | |||
| from breast lesions or | |||
| axillary lymph nodes for | |||
| histological evaluation. | |||
| The system is composed | |||
| of a base unit, a driver | |||
| and two different types | |||
| of sterile single use | |||
| probes. | Mammotome elite® | ||
| Biopsy System consists | |||
| of a reusable Holster | |||
| and a single-patient use, | |||
| sterile Probe that is | |||
| used with ultrasound | |||
| imaging guidance to | |||
| excise and collect | |||
| diagnostic samples with | |||
| a single insertion of the | |||
| Probe. | |||
| 510(k) number | TBD | K153709 | |
| Product Code | KNW, FCG (proposed) | KNW | |
| Intended Use | The NeoNavia biopsy | ||
| system is intended for | |||
| obtaining tissue | |||
| samples from both | |||
| breast lesions and | |||
| axillary lymph nodes for | |||
| diagnostic analysis of | |||
| breast abnormalities. | The Mammotome elite® | ||
| Biopsy System is | |||
| intended to provide | |||
| breast or axillary lymph | |||
| node tissue samples for | |||
| diagnostic analysis of | |||
| imaged or palpated | |||
| breast abnormalities. | Same, to provide breast | ||
| tissue and lymph node | |||
| samples for diagnostic | |||
| analysis. | |||
| Characteristics | NeoNavia® Biopsy | ||
| System (subject device) | Mammotome elite® | ||
| Biopsy System | Differences and | ||
| Comments | |||
| (Primary predicate) | |||
| Indications for Use | The FlexiPulse and | ||
| VacuPulse probes are | |||
| intended to provide | |||
| tissue from breast | |||
| lesions and axillary | |||
| lymph nodes for | |||
| histologic examination. | |||
| The NeoNavia biopsy | |||
| system is to be used | |||
| only by healthcare | |||
| professionals in | |||
| hospitals or healthcare | |||
| facilities. | The Mammotome elite® | ||
| Biopsy System is | |||
| indicated to obtain | |||
| tissue samples from the | |||
| breast or axillary lymph | |||
| nodes for diagnostic | |||
| analysis of breast | |||
| abnormalities. | |||
| • The Mammotome | |||
| elite® Biopsy System is | |||
| intended to provide | |||
| breast tissue for | |||
| histologic examination | |||
| with partial or complete | |||
| removal of the imaged | |||
| abnormality. | |||
| • The Mammotome | |||
| elite® Biopsy System is | |||
| intended to provide | |||
| breast tissue for | |||
| histologic examination | |||
| with partial removal of | |||
| a palpable abnormality. | |||
| The extent of a | |||
| histologic abnormality | |||
| cannot always be | |||
| readily 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 | NeoNavia is not | ||
| intended for complete | |||
| removal of the imaged | |||
| abnormality whereas | |||
| Mammotone is | |||
| designed to provide | |||
| breast tissue for | |||
| histologic examination | |||
| with partial or complete | |||
| removal of the imaged | |||
| abnormality. This | |||
| difference does not | |||
| affect NeoNavia's | |||
| intended use or | |||
| indications for use for | |||
| obtaining tissue | |||
| samples from both | |||
| breast lesions and | |||
| axillary lymph nodes for | |||
| diagnostic analysis of | |||
| breast abnormalities. | |||
| Characteristics | NeoNavia® Biopsy | ||
| System (subject device) | Mammotome elite® | ||
| Biopsy System | |||
| (Primary predicate) | Differences and | ||
| Comments | |||
| is essential that the | |||
| tissue margins be | |||
| examined for | |||
| completeness of | |||
| removal using standard | |||
| surgical procedures. | |||
| In instances when a | |||
| patient presents with a | |||
| palpable abnormality | |||
| that has been classified | |||
| as benign through | |||
| clinical and/or | |||
| radiological criteria | |||
| (e.g., fibroadenoma, | |||
| fibrocystic lesion), the | |||
| Mammotome elite® | |||
| Biopsy System may also | |||
| be used to partially | |||
| remove such palpable | |||
| lesions. Whenever | |||
| breast tissue is | |||
| removed, histological | |||
| evaluation of the tissue | |||
| is the standard of care. | |||
| 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. | |||
| Intended users | Healthcare | ||
| professionals | |||
| (The NeoNavia system is | |||
| to be used only by | |||
| healthcare professionals | |||
| trained in subcutaneous | |||
| biopsy procedures | Healthcare | ||
| professionals | |||
| (Minimally invasive | |||
| procedures should be | |||
| performed only by | |||
| persons having | |||
| adequate training and | Same | ||
| Characteristics | NeoNavia® Biopsy | ||
| System (subject device) | Mammotome elite® | ||
| Biopsy System | |||
| (Primary predicate) | Differences and | ||
| Comments | |||
| guided by ultrasound | |||
| imaging equipment.) | familiarity with | ||
| minimally invasive | |||
| techniques.) | |||
| Image guidance | |||
| modality | Ultrasound | Ultrasound | Same |
| Patient contacting | |||
| materials | Stainless steel | Stainless steel | Same |
| Handheld procedure? | Yes | Yes | Same |
| Method of needle | |||
| insertion and | |||
| advancement | Manual positioning | ||
| Optional short | |||
| longitudinal movement | |||
| to aid advancing the | |||
| needle millimeter by | |||
| millimeter. | Manual positioning | NeoNavia may be used | |
| manually and with short | |||
| longitudinal movement | |||
| that provides greater | |||
| control over manual | |||
| positioning. | |||
| Vacuum | Vacuum Assisted | ||
| System | Vacuum Assisted | ||
| System | Same | ||
| Single use disposable vs | |||
| Reusable device | Single use, disposable | ||
| biopsy probe; reusable | |||
| driver and base unit | Single use, disposable | ||
| biopsy probe; reusable | |||
| driver | Same |
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6
7
Table 2: Comparison of NeoNavia VacuPulse probe to predicate
| Characteristics | NeoNavia VacuPulse
configurations | Mammotome elite®
Biopsy System | Differences and
Comments |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Marketed needle size | 10 Gauge | 10 & 13 Gauge | Mammotome has an
additional smaller size
needle. |
| Method of tissue
sampling | Vacuum assisted side-cut
needle with rotating
inner cutting cannula
advanced forward to
sever tissue sample. | Vacuum assisted side-cut
needle with rotating
inner cutting cannula
advanced forward to
sever tissue sample. | Same |
| Method of sample
collection | Vacuum transport to
sample collection basket. | Vacuum transport to
sample collection basket. | Same |
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| Characteristics | NeoNavia VacuPulse
configurations | Mammotome elite®
Biopsy System | Differences and
Comments |
|-----------------|--------------------------------------|-----------------------------------|-----------------------------|
| | Multiple samples possible. | Multiple samples possible. | |
Table 3: Comparison of NeoNavia Flexipulse probe to the predicates
| Characteristics | NeoNavia FlexiPulse
configurations | Mammotome elite®
Biopsy System | Differences and
Comments |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Marketed needle size | 14 Gauge | 10 & 13 Gauge | Difference in needle sizes.
No significant impact to
substantial equivalence
per testing performed
with FlexiPulse needle as
compared to
Mammotome 10G
needle. Ref. NeoNavia
Biopsy System Needle
Size Rational report |
| Method of tissue
sampling | Front loaded vacuum
assisted needle with
rotational severing
capability, advanced
forward millimeter by
millimeter using short
longitudinal movement. | Vacuum assisted side-cut
needle with rotating
inner cutting cannula
advancing forward to
sever tissue sample. | NeoNavia needle is front
loaded compared to side
cut. Safety and
performance of
needles/probes validated
by animal testing. |
| Method of sample
collection | Single sample inside front
loaded needle. | Vacuum transport to
sample collection basket.
Multiple samples
possible. | FlexiPulse collects a single
sample whereas
Mammotome collects
multiple samples. |
Performance testing:
Sterilization, Shelf Life and Packaging
The VacuPulse and FlexiPulse probes of the NeoNavia Biopsy System are provided sterilization validation, sterile packaging validation and shelf life testing have been performed for the sterile disposable probes.
Biocompatibility Testing
9
Biocompatibility testing results for cytotoxicity, irritation, sensitization, acute systemic toxicity and materials mediated pyrogenicity indicate the NeoNavia VacuPulse probe is safe for its indicated use.
Software and Security
The Level of Concern associated with the software of the NeoNavia Biopsy System is considered to be Moderate. Testing was completed in accordance with the guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Final, 2005).
Electromagnetic Compatibility and Electrical Safety
Electromagnetic compatibility and electrical safety testing was performed on the NeoNavia Biopsy System.
Bench Testing
Various bench testing was performed for verification of the NeoNavia Biopsy System. Testing included comparison performance testing, usability validation and performance verification testing.
Animal Testing
Animal testing was conducted to compare the NeoNavia VacuPulse, NeoNavia Flexipulse and Mammotome biopsy devices. Biopsy samples from sheep and pigs were evaluated for biopsy sample quality (gross qualitative assessment and via histopathology), acute bleeding rate, and hematoma.
Conclusion
Based on the information provided the NeoNavia Biopsy System is substantially equivalent in terms of indications for use, technology and performance to the predicate devices.