NeoNavia Biopsy System

K220595 · Neodynamics AB · KNW · Sep 8, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220595
• Device Name: NeoNavia Biopsy System
• Applicant: Neodynamics AB
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Sep 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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.

Device Story

NeoNavia Biopsy System obtains tissue samples from breast lesions and axillary lymph nodes for histological evaluation. System comprises base unit, driver, and sterile single-use probes (FlexiPulse and VacuPulse). Operated under ultrasound imaging guidance by healthcare professionals in clinical settings. Probes utilize pulses to improve precision and control during needle insertion and positioning. VacuPulse uses vacuum-assisted side-cut technology; FlexiPulse uses front-loaded vacuum-assisted needle with rotational severing. Manual positioning with optional short longitudinal movement aids millimeter-by-millimeter advancement. Output is tissue sample for diagnostic analysis. Benefits include controlled, precise tissue acquisition for breast abnormality diagnosis.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (performance verification, usability validation) and animal studies (sheep and pigs) comparing NeoNavia probes to the predicate. Animal study endpoints included biopsy sample quality (gross/histopathology), acute bleeding rate, and hematoma formation.

Technological Characteristics

System includes base unit, driver, and single-use probes. Materials: stainless steel. Sensing/Actuation: vacuum-assisted, rotational severing, pulse-based needle advancement. Connectivity: standalone. Sterilization: validated for single-use probes. Software: Moderate Level of Concern.

Indications for Use

Indicated for obtaining tissue samples from breast lesions and axillary lymph nodes for histologic examination in patients with breast abnormalities. To be used by healthcare professionals in hospitals or healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Mammotome elite® Biopsy System (K153709)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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### 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: [phone] Email: [e-mail]
- LeAnn Latham Contact: M Squared Associates, Inc. 127 West 30th Street New York, NY 10001 E-mail: [e-mail] Phone: [phone] Fax [phone]

| 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<br>Device Company: Devicor® Medical Products, Inc.<br>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<br>system is designed to<br>obtain tissue samples<br>from breast lesions or<br>axillary lymph nodes for<br>histological evaluation.<br>The system is composed<br>of a base unit, a driver<br>and two different types<br>of sterile single use<br>probes. | Mammotome elite®<br>Biopsy System consists<br>of a reusable Holster<br>and a single-patient use,<br>sterile Probe that is<br>used with ultrasound<br>imaging guidance to<br>excise and collect<br>diagnostic samples with<br>a single insertion of the<br>Probe. | |
| 510(k) number | TBD | K153709 | |
| Product Code | KNW, FCG (proposed) | KNW | |
| Intended Use | The NeoNavia biopsy<br>system is intended for<br>obtaining tissue<br>samples from both<br>breast lesions and<br>axillary lymph nodes for<br>diagnostic analysis of<br>breast abnormalities. | The Mammotome elite®<br>Biopsy System is<br>intended to provide<br>breast or axillary lymph<br>node tissue samples for<br>diagnostic analysis of<br>imaged or palpated<br>breast abnormalities. | Same, to provide breast<br>tissue and lymph node<br>samples for diagnostic<br>analysis. |
| Characteristics | NeoNavia® Biopsy<br>System (subject device) | Mammotome elite®<br>Biopsy System | Differences and<br>Comments |
| | | (Primary predicate) | |
| Indications for Use | The FlexiPulse and<br>VacuPulse probes are<br>intended to provide<br>tissue from breast<br>lesions and axillary<br>lymph nodes for<br>histologic examination.<br>The NeoNavia biopsy<br>system is to be used<br>only by healthcare<br>professionals in<br>hospitals or healthcare<br>facilities. | The Mammotome elite®<br>Biopsy System is<br>indicated to obtain<br>tissue samples from the<br>breast or axillary lymph<br>nodes for diagnostic<br>analysis of breast<br>abnormalities.<br>• The Mammotome<br>elite® Biopsy System is<br>intended to provide<br>breast tissue for<br>histologic examination<br>with partial or complete<br>removal of the imaged<br>abnormality.<br>• The Mammotome<br>elite® Biopsy System is<br>intended to provide<br>breast tissue for<br>histologic examination<br>with partial removal of<br>a palpable abnormality.<br>The extent of a<br>histologic abnormality<br>cannot always be<br>readily determined<br>from the palpation or<br>imaged appearance.<br>Therefore, the extent of<br>removal of the palpated<br>or imaged evidence of<br>an abnormality does<br>not predict the extent<br>of removal of a<br>histologic abnormality,<br>e.g., malignancy. When<br>the sampled<br>abnormality is not<br>histologically benign, it | NeoNavia is not<br>intended for complete<br>removal of the imaged<br>abnormality whereas<br>Mammotone is<br>designed to provide<br>breast tissue for<br>histologic examination<br>with partial or complete<br>removal of the imaged<br>abnormality. This<br>difference does not<br>affect NeoNavia's<br>intended use or<br>indications for use for<br>obtaining tissue<br>samples from both<br>breast lesions and<br>axillary lymph nodes for<br>diagnostic analysis of<br>breast abnormalities. |
| Characteristics | NeoNavia® Biopsy<br>System (subject device) | Mammotome elite®<br>Biopsy System<br>(Primary predicate) | Differences and<br>Comments |
| | | is essential that the<br>tissue margins be<br>examined for<br>completeness of<br>removal using standard<br>surgical procedures.<br>In instances when a<br>patient presents with a<br>palpable abnormality<br>that has been classified<br>as benign through<br>clinical and/or<br>radiological criteria<br>(e.g., fibroadenoma,<br>fibrocystic lesion), the<br>Mammotome elite®<br>Biopsy System may also<br>be used to partially<br>remove such palpable<br>lesions. Whenever<br>breast tissue is<br>removed, histological<br>evaluation of the tissue<br>is the standard of care.<br>When the sampled<br>abnormality is not<br>histologically benign, it<br>is essential that the<br>tissue margins be<br>examined for<br>completeness of<br>removal using standard<br>surgical procedures. | |
| Intended users | Healthcare<br>professionals<br>(The NeoNavia system is<br>to be used only by<br>healthcare professionals<br>trained in subcutaneous<br>biopsy procedures | Healthcare<br>professionals<br>(Minimally invasive<br>procedures should be<br>performed only by<br>persons having<br>adequate training and | Same |
| Characteristics | NeoNavia® Biopsy<br>System (subject device) | Mammotome elite®<br>Biopsy System<br>(Primary predicate) | Differences and<br>Comments |
| | guided by ultrasound<br>imaging equipment.) | familiarity with<br>minimally invasive<br>techniques.) | |
| Image guidance<br>modality | Ultrasound | Ultrasound | Same |
| Patient contacting<br>materials | Stainless steel | Stainless steel | Same |
| Handheld procedure? | Yes | Yes | Same |
| Method of needle<br>insertion and<br>advancement | Manual positioning<br>Optional short<br>longitudinal movement<br>to aid advancing the<br>needle millimeter by<br>millimeter. | Manual positioning | NeoNavia may be used<br>manually and with short<br>longitudinal movement<br>that provides greater<br>control over manual<br>positioning. |
| Vacuum | Vacuum Assisted<br>System | Vacuum Assisted<br>System | Same |
| Single use disposable vs<br>Reusable device | Single use, disposable<br>biopsy probe; reusable<br>driver and base unit | Single use, disposable<br>biopsy probe; reusable<br>driver | Same |

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### Table 2: Comparison of NeoNavia VacuPulse probe to predicate

| Characteristics | NeoNavia VacuPulse<br>configurations | Mammotome elite®<br>Biopsy System | Differences and<br>Comments |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Marketed needle size | 10 Gauge | 10 & 13 Gauge | Mammotome has an<br>additional smaller size<br>needle. |
| Method of tissue<br>sampling | Vacuum assisted side-cut<br>needle with rotating<br>inner cutting cannula<br>advanced forward to<br>sever tissue sample. | Vacuum assisted side-cut<br>needle with rotating<br>inner cutting cannula<br>advanced forward to<br>sever tissue sample. | Same |
| Method of sample<br>collection | Vacuum transport to<br>sample collection basket. | Vacuum transport to<br>sample collection basket. | Same |

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| Characteristics | NeoNavia VacuPulse<br>configurations | Mammotome elite®<br>Biopsy System | Differences and<br>Comments |
|-----------------|--------------------------------------|-----------------------------------|-----------------------------|
| | Multiple samples possible. | Multiple samples possible. | |

#### Table 3: Comparison of NeoNavia Flexipulse probe to the predicates

| Characteristics | NeoNavia FlexiPulse<br>configurations | Mammotome elite®<br>Biopsy System | Differences and<br>Comments |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Marketed needle size | 14 Gauge | 10 & 13 Gauge | Difference in needle sizes.<br>No significant impact to<br>substantial equivalence<br>per testing performed<br>with FlexiPulse needle as<br>compared to<br>Mammotome 10G<br>needle. Ref. NeoNavia<br>Biopsy System Needle<br>Size Rational report |
| Method of tissue<br>sampling | Front loaded vacuum<br>assisted needle with<br>rotational severing<br>capability, advanced<br>forward millimeter by<br>millimeter using short<br>longitudinal movement. | Vacuum assisted side-cut<br>needle with rotating<br>inner cutting cannula<br>advancing forward to<br>sever tissue sample. | NeoNavia needle is front<br>loaded compared to side<br>cut. Safety and<br>performance of<br>needles/probes validated<br>by animal testing. |
| Method of sample<br>collection | Single sample inside front<br>loaded needle. | Vacuum transport to<br>sample collection basket.<br>Multiple samples<br>possible. | FlexiPulse collects a single<br>sample whereas<br>Mammotome collects<br>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

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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.