The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

Device Description

The sterile, single use, Morrison Steerable Needle consists of the housing, a rotating lever which controls the deflection of the needle tip, the slide, the collar which transfers tensile force from the slide to the core wire; the tendon wire (core wire) which transfers tensile force from the collar to distal tip of the tubing; the stainless steel tubing which ends in a Menghini like needle tip on the distal end and a luer lock fitting on the proximal end.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Morrison Steerable Needle, asserting its substantial equivalence to previously marketed predicate devices. It covers the device's description, indications for use, comparison with predicate devices, and performance data, but it does not contain the specific information requested in the prompt regarding acceptance criteria for an AI/CAD/software device, or a study proving that the device meets such criteria.

The document is for a physical medical device (a steerable needle), not an AI/CAD/software product. Therefore, it does not discuss topics such as:

Acceptance criteria for an AI/CAD/software device: The document focuses on regulatory equivalence based on design, materials, intended use, and performance of a physical needle, not performance metrics like sensitivity, specificity, or F1-score for an algorithm.
Study proving the device meets AI/CAD/software acceptance criteria: There is no mention of such a study. The performance testing described is for biocompatibility, needle advancement, injection/aspiration, tissue sampling, and animal safety for a physical needle.
Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set size, or how ground truth for training set was established: These are all concepts relevant to the evaluation of AI/CAD/software devices, which are not applicable to the physical device described in this document.

In summary, the provided text does not contain any of the information requested in the prompt as it pertains to an AI/CAD/software device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2015

AprioMed AB Mr. Bruno Edling Quality Manager Virdings Allé 28 754 50 Uppsala SWEDEN

Re: K150625

Trade/Device Name: Morrison Steerable Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: February 5, 2015 Received: March 11, 2015

Dear Mr. Edling:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 Indications for Use Statement

K150625 510(k) Number (if known):

Morrison Steerable Needle Device Name:

The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED

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ਟ 510(k) Summary (per 21 CFR 807.92(c))

5.1 Submitter/510(k) Holder

AprioMed AB Virdings Allé 28 Uppsala, SWEDEN 754 50

Contact Person: Bruno Edling, Quality Manager Telephone: +46184301445

Date Prepared: February 5, 2015

5.2 Device

Proprietary Name:	Morrison Steerable Needle
Common/Usual Names:	Biopsy Needle
Classification Names:	Instrument Biopsy
510(k) number:	K150625
Product Code:	KNW

5.3 Predicate Devices

Legally marketed Biopsy Instruments used for the same indications for use:

Proprietary Name:	Angiotech Chiba Biopsy Needle (Former Manan Soft TissueBiopsy Needle)
Common/Usual Names:	Angiotech Chiba Biopsy Needle
Classification Names:	Instrument Biopsy
510(k) number:	K980122
Product Code:	KNW
Proprietary Name:	Pan Chiba Cytological Aspirating Biopsy Needle
Common/Usual Names:	Pan Chiba Cytological Aspirating Biopsy Needle
Classification Names:	Instrument Biopsy
510(k) number:	K970872
Product Code:	KNW

5.4 Device Description

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When the lever is rotated, the rotational force is transferred in the cam curve into tensile force on the slide which is pulled towards the proximal end of the device. The slide brings the collar and the proximal end of the core wire along and transfers the tensile force to the distal tip of the tubing, where the tensile force is transferred into bending force at the notch, causing the distal needle tip to bend towards the lever. The maximum deployment of the lever (125°) causes a 2 mm movement of collar producing a needle tip displacement of 10 mm. Since lever adjustment is seamless, any lever adjustment between 0-125° can be achieved, producing a needle tip displacement of 0-10 mm.

The materials used for construction of the Morrison Steerable Needle are typical for this type of medical device. The only material in direct patient contact is stainless steel AISI 304, commonly used in medical devices.

5.5 Indications for Use

The Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

The Intended use for the legally marketed devices are:

For the Manan device; The Manan soft tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Floroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

And;

For the PAN device; This device is to be used for taking cyto-histological biopsies of soft tissue

Though the indication for use descriptions are not exactly the same, the meaning is essentially the same. All devices are intended for the same procedure in soft tissue

5.6 Comparison of Technological Characteristics of Morrison Steerable Needle Compared to Legally Marketed Biopsy Needles Used for the Same Indications for Use

AprioMed AB has determined that the Morrison Steerable is substantially equivalent to legally marketed devices based on the Indications for Use, compliance with internationally recognized design and performance standards, materials specifications, use environments, and performance. The determination of equivalence is also based on the fact that the differences between the Morrison Steerable Needle and legally marketed rigid needles used for the same Indications for Use do not raise new issues of safety and effectiveness based on the formal risk analysis.

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Information and data presented in this 510(k) shows that Morrison Steerable Needle is equivalent to the legally marketed devices and does not raise new issues of safety or effectiveness.

A side-by-side comparison of the Morrison Steerable and the applicable legally marketed devices is provided in Table 5-1 below.

Parameter	Morrison SteerableNeedle	Angiotech Chiba 20G15cm/22G 15cm	Pan Chiba20G 20cm/22G 20cm	EquivalentYes/No
510(k) no.	K150625	K980122	K970872	N/A
ProprietaryName	Morrison SteerableNeedle	Manan Soft TissueBiopsy Needles	Pan ApiratingNeedle (Chiba)	N/A
DeviceClassificationName	Instrument, Biopsy	Instrument, Biopsy	Instrument, Biopsy	YES
Product Code	KNW	KNW	KNW	YES
Regulationdescription	Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument	Gastroenterology-urology biopsyinstrument	YES
RegulationNumber	21 CFR 878.1075	21 CFR 878.1075	21 CFR 878.1075	YES
Intended Use/Indications forUse	The MorrisonSteerable Needle isintended forpercutaneous injectionand aspirationprocedures, and tissuesampling in kidney,liver, muscle andsubcutaneous tissue.	The Manan soft tissueBiopsy Needles areintended to be used inpercutaneous soft tissue(pleura cavityassociated organs,abdominal cavity andassociated organs, etc.)biopsies effected via theinsertion of device by aqualified physician,under guidance (CT,Ultrasound, SequentialMammography, orFloroscopy), andmanipulated in such amanner that a tissuespecimen is retainedwithin a collectionorifice on the needle.	This device is to beused for taking cyto-histological biopsiesof soft tissue	YES
Visualizationtechnique	Conventional imagingguidance equipmentexcluding MRI	Conventional imagingguidance equipmentexcluding MRI	Conventionalimaging guidanceequipment excludingMRI	YES
Single Use	Yes	Yes	Yes	YES
Sterile	Yes	Yes	Yes	YES
Parameter	Morrison SteerableNeedle	Angiotech Chiba 20G15cm/22G 15cm	Pan Chiba20G 20cm/22G 20cm	EquivalentYes/No
Needlematerial	Medical gradeStainless Steel	Medical grade StainlessSteel	Medical gradeStainless Steel	YES
Needle Hub	Luer hub	Luer hub	Luer hub	YES
Needle size	21G 17cm	20G 15cm/22G 15 cm	20G 20cm	YES
Stylet Size	OD: 0,64 mm	OD 20G: 0.60mm/ OD22G: 0.40mm	OD 20G: 0.60mm/OD 22G: 0.40mm	YES
Needleadvancement/penetrationdepth	17cm free length	15cm free length	20cm free length	YES
Sample notchsize	N/A Device does nothave sample notch	N/A Device does nothave sample notch	N/A Device does nothave sample notch	YES
Number ofsamples	N/A as the device isnot a Biopsy Gun	N/A as the device is nota Biopsy Gun	N/A as the device isnot a Biopsy Gun	YES
Safety features	N/A no specific safetyfeatures	N/A no specific safetyfeatures	N/A no specificsafety features	YES
Anatomicalsites	Liver, kidney, muscleand subcutaneoustissue	Pleura cavity associatedorgans, abdominalcavity and associatedorgans, etc	Soft tissue	YES
Steerable	Yes	No	No	YES

Table 5-1. Comparison of the Morrison Steerable Needle with Legally Marketed Devices

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A summary of the basis for the determination of substantial equivalence is described below.

5.6.1 Intended Use/Indication for Use

AprioMed has determined that the Morrison Steerable is substantially equivalent to the legally marketed devices based on intended use/indications for use. Though the indication for use descriptions are not exactly the same, the meaning is essentially the same. All devices are intended for the same procedure in soft tissue

5.6.2 Materials

AprioMed has determined that the Morrison Steerable is substantially equivalent to legally marketed devices based on materials. Both the Morrison Steerable Needle and legally marketed devices are constructed with medical grade stainless steel.

5.6.3 Use Environment

AprioMed has determined that the Morrison Steerable is substantially equivalent to legally marketed devices based on the use environment. Both the Morrison Steerable Needle and legally marketed needles/devices are used under conventional imaging guidance equipment excluding MRI. The users are physicians trained in image guided injection/ aspiration procedures and tissue sampling.

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5.6.4 Fundamental Design

Size, stylet size and penetration depth

AprioMed has determined that the Morrison Steerable Needle size, stylet size and penetration depth is substantially equivalent to legally marketed devices.

Sample notch size

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to sample notch size. Sample notch is not present in the design of the Morrison Steerable needle or any of the state of the art predicate devices. Sample notch is present on gastroenterological biopsy guns but not on biopsy needles.

Number of samples

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to number of samples. Neither the Morrison Steerable needle nor the predicates specifies number of samples. To specify number of samples is a requirement for Biopsy guns as there is a known risk of mechanical failure when using this type of devices, and there is no such risk for biopsy needles.

Safety features

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to safety features. Neither the Morrison Steerable needle nor the predicates has any specific safety features.

5.7 Performance Data

Biocompatibility testing 5.7.1

The Morrison Steerable Needle has successfully been tested for:

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●

The testing results verify that the biocompatibility criteria given in ISO 10993 are fulfilled.

Based on the test reports, AprioMed concludes that the Morrison Steerable is nontoxic and biocompatible.

5.7.2 Perfomance testing bench

Needle advancement

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to needle advancement. The Morrison Steerable Needle can access the targeted tissue and give an accurate needle advancement and penetration when compared with similar predicate devices advanced in intended anatomical sites, the control

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article and test articles were equivalent in terms of needle advancement accuracy and penetration force.

Injection/Aspiration

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to Injection/ Aspiration. The procedures for Injection and Aspiration, are identical for all needles.

Tissue sampling

AprioMed believes that the Morrison Steerable is substantially equivalent to legally marketed devices with respect to demonstrating that the Morrison Steerable Needle is able to collect an appropriate amount of tissue for biopsy, as compared to the predicate devices in the anatomical sites; muscle, kidney, liver and subcutaneous tissue.

Tissue sampling for the Morrison Needle and the predicates demonstrates that the device is able to collect at least as much tissue for biopsy, as compared to the predicate devices in the anatomical sites; muscle, kidney, liver and subcutaneous tissue.

(See APPENDICE 18-4 R1489 Performance testing bench Morrison Steerable Needle)

Performance testing Animal 5.7.3

To further test the safety of using the Morrison Steerable Needle an in vivo Animal Safety study has been performed (see Section 19 and associated APPENDICES). The evaluation and testing is summarized below.

The study successfully achieved the objective of demonstrating that the Morrison steerable needle is significantly comparable in safety to the 20 and 22 Gauge Pan Chiba and 20 and 22 Gauge Angiotech Chiba biopsy needles.

Summary and Conclusions 5.8

Based on the above discussion. AprioMed has determined that Morrison Steerable is equivalent to the predicates. AprioMed has demonstrated the safety of using the Morrison Steerable Needle, when compared to the prediactes, under the indication percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.

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.