(191 days)
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.
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.
The provided text does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in clinical performance studies of AI/ML devices.
The document is a 510(k) premarket notification summary for the NeoNavia Biopsy System, which is a medical device for obtaining tissue samples. The majority of the document focuses on comparing the NeoNavia Biopsy System to predicate devices and describes various performance testing categories (sterilization, biocompatibility, software, electromagnetic compatibility, bench testing, animal testing).
Here's what can be extracted based on the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in the format of a table as typically seen for AI/ML device performance. Instead, it describes general performance testing conducted, indicating that the device "is substantially equivalent in terms of indications for use, technology and performance to the predicate devices."
The closest to "reported performance" is the mention of animal testing where "Biopsy samples from sheep and pigs were evaluated for biopsy sample quality (gross qualitative assessment and via histopathology), acute bleeding rate, and hematoma." However, no specific numerical results or target acceptance criteria for these evaluations are provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the animal testing, the document mentions "biopsy samples from sheep and pigs." However, the exact number of animals or the total number of biopsy samples taken is not specified.
- Data Provenance: The data comes from "animal testing" involving "sheep and pigs." No information regarding country of origin or whether it was retrospective or prospective is explicitly stated, though animal testing is inherently prospective experimentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not state the number or qualifications of experts used to establish ground truth for the animal study. It mentions that biopsy samples were evaluated via "histopathology," which implies assessment by pathologists, but no further details are given.
4. Adjudication Method for the Test Set:
No adjudication method is described for the animal study or any other part of the testing mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No MRMC comparative effectiveness study is mentioned. This device is a biopsy system, not an AI/ML diagnostic aid that would typically involve human readers interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable as the NeoNavia Biopsy System is a physical device (biopsy system) and not an AI algorithm. The software mentioned has a "Moderate" level of concern, but its performance is discussed in terms of general software guidelines, not in a standalone diagnostic capacity.
7. Type of Ground Truth Used:
For the animal testing, the ground truth for biopsy sample quality was established via histopathology.
8. Sample Size for the Training Set:
This question is not applicable as the document describes a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable.
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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
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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 (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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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 SystemDevice 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® biopsysystem is designed toobtain tissue samplesfrom breast lesions oraxillary lymph nodes forhistological evaluation.The system is composedof a base unit, a driverand two different typesof sterile single useprobes. | Mammotome elite®Biopsy System consistsof a reusable Holsterand a single-patient use,sterile Probe that isused with ultrasoundimaging guidance toexcise and collectdiagnostic samples witha single insertion of theProbe. | |
| 510(k) number | TBD | K153709 | |
| Product Code | KNW, FCG (proposed) | KNW | |
| Intended Use | The NeoNavia biopsysystem is intended forobtaining tissuesamples from bothbreast lesions andaxillary lymph nodes fordiagnostic analysis ofbreast abnormalities. | The Mammotome elite®Biopsy System isintended to providebreast or axillary lymphnode tissue samples fordiagnostic analysis ofimaged or palpatedbreast abnormalities. | Same, to provide breasttissue and lymph nodesamples for diagnosticanalysis. |
| Characteristics | NeoNavia® BiopsySystem (subject device) | Mammotome elite®Biopsy System | Differences andComments |
| (Primary predicate) | |||
| Indications for Use | The FlexiPulse andVacuPulse probes areintended to providetissue from breastlesions and axillarylymph nodes forhistologic examination.The NeoNavia biopsysystem is to be usedonly by healthcareprofessionals inhospitals or healthcarefacilities. | The Mammotome elite®Biopsy System isindicated to obtaintissue samples from thebreast or axillary lymphnodes for diagnosticanalysis of breastabnormalities.• The Mammotomeelite® Biopsy System isintended to providebreast tissue forhistologic examinationwith partial or completeremoval of the imagedabnormality.• The Mammotomeelite® Biopsy System isintended to providebreast tissue forhistologic examinationwith partial removal ofa palpable abnormality.The extent of ahistologic abnormalitycannot always bereadily determinedfrom the palpation orimaged appearance.Therefore, the extent ofremoval of the palpatedor imaged evidence ofan abnormality doesnot predict the extentof removal of ahistologic abnormality,e.g., malignancy. Whenthe sampledabnormality is nothistologically benign, it | NeoNavia is notintended for completeremoval of the imagedabnormality whereasMammotone isdesigned to providebreast tissue forhistologic examinationwith partial or completeremoval of the imagedabnormality. Thisdifference does notaffect NeoNavia'sintended use orindications for use forobtaining tissuesamples from bothbreast lesions andaxillary lymph nodes fordiagnostic analysis ofbreast abnormalities. |
| Characteristics | NeoNavia® BiopsySystem (subject device) | Mammotome elite®Biopsy System(Primary predicate) | Differences andComments |
| is essential that thetissue margins beexamined forcompleteness ofremoval using standardsurgical procedures.In instances when apatient presents with apalpable abnormalitythat has been classifiedas benign throughclinical and/orradiological criteria(e.g., fibroadenoma,fibrocystic lesion), theMammotome elite®Biopsy System may alsobe used to partiallyremove such palpablelesions. Wheneverbreast tissue isremoved, histologicalevaluation of the tissueis the standard of care.When the sampledabnormality is nothistologically benign, itis essential that thetissue margins beexamined forcompleteness ofremoval using standardsurgical procedures. | |||
| Intended users | Healthcareprofessionals(The NeoNavia system isto be used only byhealthcare professionalstrained in subcutaneousbiopsy procedures | Healthcareprofessionals(Minimally invasiveprocedures should beperformed only bypersons havingadequate training and | Same |
| Characteristics | NeoNavia® BiopsySystem (subject device) | Mammotome elite®Biopsy System(Primary predicate) | Differences andComments |
| guided by ultrasoundimaging equipment.) | familiarity withminimally invasivetechniques.) | ||
| Image guidancemodality | Ultrasound | Ultrasound | Same |
| Patient contactingmaterials | Stainless steel | Stainless steel | Same |
| Handheld procedure? | Yes | Yes | Same |
| Method of needleinsertion andadvancement | Manual positioningOptional shortlongitudinal movementto aid advancing theneedle millimeter bymillimeter. | Manual positioning | NeoNavia may be usedmanually and with shortlongitudinal movementthat provides greatercontrol over manualpositioning. |
| Vacuum | Vacuum AssistedSystem | Vacuum AssistedSystem | Same |
| Single use disposable vsReusable device | Single use, disposablebiopsy probe; reusabledriver and base unit | Single use, disposablebiopsy probe; reusabledriver | Same |
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Table 2: Comparison of NeoNavia VacuPulse probe to predicate
| Characteristics | NeoNavia VacuPulseconfigurations | Mammotome elite®Biopsy System | Differences andComments |
|---|---|---|---|
| Marketed needle size | 10 Gauge | 10 & 13 Gauge | Mammotome has anadditional smaller sizeneedle. |
| Method of tissuesampling | Vacuum assisted side-cutneedle with rotatinginner cutting cannulaadvanced forward tosever tissue sample. | Vacuum assisted side-cutneedle with rotatinginner cutting cannulaadvanced forward tosever tissue sample. | Same |
| Method of samplecollection | Vacuum transport tosample collection basket. | Vacuum transport tosample collection basket. | Same |
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| Characteristics | NeoNavia VacuPulseconfigurations | Mammotome elite®Biopsy System | Differences andComments |
|---|---|---|---|
| Multiple samples possible. | Multiple samples possible. |
Table 3: Comparison of NeoNavia Flexipulse probe to the predicates
| Characteristics | NeoNavia FlexiPulseconfigurations | Mammotome elite®Biopsy System | Differences andComments |
|---|---|---|---|
| Marketed needle size | 14 Gauge | 10 & 13 Gauge | Difference in needle sizes.No significant impact tosubstantial equivalenceper testing performedwith FlexiPulse needle ascompared toMammotome 10Gneedle. Ref. NeoNaviaBiopsy System NeedleSize Rational report |
| Method of tissuesampling | Front loaded vacuumassisted needle withrotational severingcapability, advancedforward millimeter bymillimeter using shortlongitudinal movement. | Vacuum assisted side-cutneedle with rotatinginner cutting cannulaadvancing forward tosever tissue sample. | NeoNavia needle is frontloaded compared to sidecut. Safety andperformance ofneedles/probes validatedby animal testing. |
| Method of samplecollection | Single sample inside frontloaded needle. | Vacuum transport tosample collection basket.Multiple samplespossible. | FlexiPulse collects a singlesample whereasMammotome collectsmultiple 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.
§ 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.