(90 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and functionality of a steerable needle, with no mention of AI or ML algorithms for image analysis, guidance, or any other function.
No
The device is used for percutaneous injection, aspiration, and tissue sampling, which are diagnostic or procedural functions, not directly therapeutic. While these procedures might be part of a therapeutic pathway, the device itself is not providing a therapy.
No
The device is intended for percutaneous injection, aspiration, and tissue sampling, which are interventional procedures, not diagnostic ones. While the collected tissue might be used for subsequent diagnostic analysis, the device itself is a tool for obtaining the sample or performing an intervention, not for diagnosing.
No
The device description clearly outlines physical components like housing, rotating lever, slide, collar, tendon wire, and stainless steel tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous injection, aspiration, and tissue sampling in the body (kidney, liver, muscle, subcutaneous tissue). IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The device is a needle designed for direct interaction with tissues within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples in vitro (in a lab setting). The device is used for obtaining samples or delivering substances directly into the patient.
The device is a medical device used for interventional procedures, not for diagnostic testing performed on samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Conventional imaging guidance equipment excluding MRI
Anatomical Site
kidney, liver, muscle and subcutaneous tissue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained in image guided injection/ aspiration procedures and tissue sampling./ Not Found
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)
Biocompatibility testing: The Morrison Steerable Needle has successfully been tested for cytotoxicity, sensitization, irritation, and acute systemic toxicity. The testing results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Conclusion: the Morrison Steerable is nontoxic and biocompatible.
Performance testing bench:
- 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 article and test articles were equivalent in terms of needle advancement accuracy and penetration force.
- Injection/Aspiration: The procedures for Injection and Aspiration, are identical for all needles.
- Tissue sampling: The device 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.
Performance testing Animal: An in vivo Animal Safety study has been performed. 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.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are stacked slightly offset from each other. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
1
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
2
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 Tissue
Biopsy 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
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.
4
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 Steerable
Needle | Angiotech Chiba 20G
15cm/
22G 15cm | Pan Chiba
20G 20cm/
22G 20cm | Equivalent
Yes/No |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------|
| 510(k) no. | K150625 | K980122 | K970872 | N/A |
| Proprietary
Name | Morrison Steerable
Needle | Manan Soft Tissue
Biopsy Needles | Pan Apirating
Needle (Chiba) | N/A |
| Device
Classification
Name | Instrument, Biopsy | Instrument, Biopsy | Instrument, Biopsy | YES |
| Product Code | KNW | KNW | KNW | YES |
| Regulation
description | Gastroenterology-
urology biopsy
instrument | Gastroenterology-
urology biopsy
instrument | Gastroenterology-
urology biopsy
instrument | YES |
| Regulation
Number | 21 CFR 878.1075 | 21 CFR 878.1075 | 21 CFR 878.1075 | YES |
| Intended Use/
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 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. | This device is to be
used for taking cyto-
histological biopsies
of soft tissue | YES |
| Visualization
technique | Conventional imaging
guidance equipment
excluding MRI | Conventional imaging
guidance equipment
excluding MRI | Conventional
imaging guidance
equipment excluding
MRI | YES |
| Single Use | Yes | Yes | Yes | YES |
| Sterile | Yes | Yes | Yes | YES |
| Parameter | Morrison Steerable
Needle | Angiotech Chiba 20G
15cm/
22G 15cm | Pan Chiba
20G 20cm/
22G 20cm | Equivalent
Yes/No |
| Needle
material | Medical grade
Stainless Steel | Medical grade Stainless
Steel | Medical grade
Stainless 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/ OD
22G: 0.40mm | OD 20G: 0.60mm/
OD 22G: 0.40mm | YES |
| Needle
advancement/penetration
depth | 17cm free length | 15cm free length | 20cm free length | YES |
| Sample notch
size | N/A Device does not
have sample notch | N/A Device does not
have sample notch | N/A Device does not
have sample notch | YES |
| Number of
samples | N/A as the device is
not a Biopsy Gun | N/A as the device is not
a Biopsy Gun | N/A as the device is
not a Biopsy Gun | YES |
| Safety features | N/A no specific safety
features | N/A no specific safety
features | N/A no specific
safety features | YES |
| Anatomical
sites | Liver, kidney, muscle
and subcutaneous
tissue | Pleura cavity associated
organs, abdominal
cavity and associated
organs, 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
8
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.