The Spirotome Endo is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities of the internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.

Device Description

The Spirotome Endo is a core biopsy device. It consists of a stainless steel receiving needle with a helical shape, stainless steel cutting cannula, and a polypropylene releasing element. The receiving needle is inserted though the cutting cannula prior to advancing to the biopsy site. The receiving needle is rotated clockwise into the tissue using the plastic hub on the proximal end. The cutting cannula is then rotated clockwise to separate the biopsy sample from the surrounding tissue. Following retraction from the biopsy site, the releasing element is used to remove the tissue sample from the receiving needle. The receiving needle is rotated counter-clockwise to release the tissue. The Spirotome Endo is operated manually.

The Spirotome Endo has four variants: one 8 gauge, and two 14 gauge needles. The receiving needle is 375 mm in length and the cutting cannula is 325 mm long. The helical needle is 18 mm long in all the variants except one 14 gauge variant, where it is 10 mm long. The device is provided sterile and is for single-use only.

AI/ML Overview

A. Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document for the Spirotome Endo device itself. The document focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, based on shared design principles, materials, manufacturing, and clinical literature. Specific performance metrics related to biopsy sample quality or diagnostic accuracy are not detailed.

B. Sample Size and Data Provenance

The document refers to leveraging "functional testing" from prior devices (Spirotome SU K060384 and Spirotome Cervicore K080095) for the Spirotome Endo. However, it does not specify the sample sizes used for these functional tests.

For the claim of "safe and effective use of the subject device for internal female reproductive organs," the document cites "clinical use of the Spirotome Endo for gynecological tissues... reported in peer reviewed journals." The number of patients or samples in these literature reports is not provided, nor is the country of origin explicitly stated, though "clinical use" suggests prospective patient data. The provenance of this data is retrospective, as it refers to existing peer-reviewed publications.

C. Number and Qualifications of Experts for Ground Truth

The document does not describe the establishment of ground truth by experts for a specific test set. Instead, it relies on clinical literature to support safety and effectiveness. Therefore, the number and qualifications of experts for ground truth are not applicable in the context of a specific study described here. The "histological and biomolecular detection and confirmation" mentioned in the Indications for Use imply the involvement of pathologists or other specialists in clinical practice, but not for a dedicated ground truth study within this submission.

D. Adjudication Method

No adjudication method is described, as there isn't a stated ground truth study involving expert review for a test set within this document.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on demonstrating substantial equivalence through non-clinical bench testing and existing clinical literature, rather than comparing human reader performance with and without AI assistance.

F. Standalone (Algorithm Only) Performance Study

This device is a physical biopsy instrument, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.

G. Type of Ground Truth Used

The ground truth implicitly relied upon for demonstrating the device's utility in providing adequate tissue samples for diagnosis is histology and biomolecular detection and confirmation as performed in routine clinical practice based on the collected tissue. This is inferred from the device's "Indications for Use" which state it is intended "to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities." However, this is not a ground truth established for a specific study within this submission but rather the expected clinical outcome.

H. Sample Size for Training Set

No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.

I. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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May 24, 2019

Bioncise NV Jaak Janssens CEO Bodemstraat 16 Wellen, Limburg Belgium 3830

Re: K190378

Trade/Device Name: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: QHC Dated: February 20, 2019 Received: February 25, 2019

Dear Jaak Janssens:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).

Sincerely,

Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology 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) K190378

Device Name

Spirotome Endo 08 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix

Indications for Use (Describe)

The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K190378

Submitter Information:

Bioncise NV Bodemstraat 16 Wellen, Limburg Belgium 3830

Contact:

Name:	Jaak JanssensCEO Bioncise NV
Telephone:	+3211271557
Fax:	+3211283677
E-mail:	jaak.janssens@bioncise.com
Date prepared:	May 23, 2019

Device Identification:

Trade Name:	Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Common Name:	Core Biopsy Instrument
Regulation Number:	21 CFR 876.1075
Regulation Name:	Gastroenterology-Urology Biopsy Instrument
Product Code:	QHC
Regulatory Class:	Class II

Predicate Device Information

Spirotome Cervicore (K080095)

The predicate device has not been subject to a design-related recall.

Device Description

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Indications for Use

The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue.

Substantial Equivalence Discussion

Attribute	Spirotome Endo - Subject Device	Spirotome Cervicore -Predicate Device
Manufacturer	Bioncise NV	Medinvents
510(k) Number	K190378	K080095
Indications for Use	The Spirotome Endo is a family oflarge core soft tissue biopsy medicaldevices to be used in humans to takeout adequate samples of tissue.The Spirotome Endo is intended toprovide soft tissue for histologicaland biomolecular detection andconfirmation of imagedabnormalities of the internal femalereproductive organs such as uterus,ovaries, and retroperitoneal lymphnodes.	The Cervicore system is a family ofcore soft tissue biopsy medicaldevices to be used in humans to takeout adequate samples of tissue fromthe human cervix.The Cervicore system is intended toprovide soft tissue for histologicaland biomolecular detection andconfirmation of imagedabnormalities by inspection orcolposcopy.The Cervicore system is intended toprovide soft tissue for histologicaland biomolecular detection andconfirmation of palpableabnormalities.An early detection and correctdiagnosis is a prerequisite for asuccessful multimodality treatmentof malignant disease. Therefore, anadequate sampling of human tissueis necessary to make a reliablediagnosis of benignancy ormalignancy and to characterize ascomplete as possible the nature ofthe lesion without unnecessarydiscomfort to the patient.In case of malignancy, a propermultimodality treatment is necessaryi.e. surgery and/orchemotherapy and/or hormonetherapy and/or biological therapy. Incase of benignancy, adequate follow-up of the patient can be provided.
Biopsy TissueTypes	Uterine, ovarian, and retroperitoneallymph nodes	Cervical

Table 1: Substantial Equivalence Comparison

Bioncise NV – Bodemstraat 16 – 3830 Wellen – Belgium www.bioncise.com – info@bioncise.com tel + 32 11 271557 - fax + 32 11 283677

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DeviceComponents	Cutting Cannula	Cutting Cannula
	Receiving Needle	Receiving Needle
	Releasing Element	Releasing Element
Helical NeedleLength	10, 18 mm	10, 20 mm
ComponentLength	Receiving Needle: 375 mm	Receiving Needle: 384.5 mm
	Cutting Cannula: 325 mm	Cutting Cannula: 350 mm
Device Materials	Stainless steel, polycarbonate,polypropylene	Stainless steel, polycarbonate,polypropylene
Sterilization	Steam Sterilized	Steam Sterilized
Number of Uses	Single-use; disposable	Single-use; disposable
Shelf Life	Three years	Three years

The Spirotome Endo and the predicate device (K080095) do not have identical Indications for Use statements. The indication for the subject device includes different biopsy tissue types and does not include statements referring to diagnosis or treatment. This change does not represent a new intended use as the intended use of this device is the same as the predicate – to provide soft tissue biopsy samples.

Non-Clinical Performance Testing

Bench Testing

Bench testing of the subject device, Spirotome Endo, including functional testing, biocompatibility, sterilization and package testing was leveraged from testing conducted on the Spirotome SU (K060384) and Spirotome Cervicore (K080095). The subject device has identical packaging materials, materials of construction, manufacturing, and sterilization processes as the cleared devices.

Literature

As part of demonstrating substantial equivalence to the predicate, literature was provided demonstrating safe and effective use of the subject device for internal female reproductive organs. Clinical use of the Spirotome Endo for gynecological tissues was reported in peer reviewed journals. The reports in clinical literature supported an acceptable safety profile for the subject device during biopsy procedures. The reports did not raise additional concerns regarding the safety and effectiveness of the subject device.

Conclusion

The results of the information and testing described above demonstrate that the Spirotome Endo is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.