(102 days)
The Merit Majestik® Shielded Angiography Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates a safety mechanism to help minimize needlestick injuries after use.
The Merit Majestik Shielded Angiography Needle is a safety-engineered angiography needle that is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates an integral, user-activated needle shield (safety feature) that is activated once a conventional vessel puncture procedure has concluded. The Majestik Shielded Angiography Needle will provide clinicians with a safety version of the legally marketed pre-amendment Majestik Angiography Needle (or equivalent) currently used during Cardiology and Radiology procedures. The Majestik Shielded Angiography Needle incorporates a clear standard female luer locking connector for immediate bleedback visualization and is color coded for needle gauge identification. A one-piece, color coded folding needle shield, linked with "living hinges" is bonded to the female luer locking connector. The needle shield is color coded to match the luer connector for immediate needle gauge identification. The Majestik Shielded Angiography Needle is offered with the needle shield in two orientations: 1) oriented vertically to the ground bevel side of the needle; or 2) oriented 90 degrees to the ground bevel side of the needle. The Majestik Shielded Angiography Needle is a single use device supplied sterile and non-pyrogenic.
The Merit Medical Systems, Inc. Majestik® Shielded Angiography Needle received 510(k) clearance (K022117) by demonstrating substantial equivalence to predicate devices and meeting acceptance criteria through a series of bench and simulated use tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria for each test performed. Instead, it states that the device "met all acceptance criteria of the tests performed." The tests conducted and the reported performance are summarized below:
| Acceptance Criteria Category (Implied) | Specific Test Conducted | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Dimensions | Met all acceptance criteria |
| Structural Integrity | Strength of bonds and hinges | Met all acceptance criteria |
| Safety Feature Functionality | Force to activate the safety feature | Met all acceptance criteria |
| Puncture Prevention | Puncture resistance of shield or sheath: the force to failure (puncture) | Met all acceptance criteria |
| Material Compatibility | Biocompatibility | Met all acceptance criteria |
| Clinical Simulation | Simulated Clinical Use | Met all acceptance criteria |
| Overall Safety Assessment | FMEA (Failure Mode and Effects Analysis) | Risks associated with use were found acceptable |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test or the "test set" in terms of a patient cohort. The tests were "bench and simulated use tests."
- Sample Size for Test Set: Not explicitly stated. The nature of bench and simulated use tests typically involves testing a statistically significant number of device units.
- Data Provenance: The tests were conducted "in-house" according to "in-house test protocols" and “recognized standards.” The information provided does not indicate the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical studies involving human subjects, which this was not.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this submission. The "ground truth" for the performance tests of this medical device (a needle) was established through engineering specifications, recognized standards, and in-house protocols for physical and functional performance. It did not involve expert consensus on medical images, pathology, or clinical diagnosis.
4. Adjudication Method for Test Set:
This section is not applicable as the "test set" refers to bench and simulated use tests focused on engineering and functional performance, not clinical data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. The device is an angiography needle with a safety feature, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance Study:
This section is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance was based on:
- Engineering specifications and design requirements: For aspects like dimensions, strength of bonds, and force to activate the safety feature.
- Recognized standards: The document explicitly mentions following "FDA's Supplementary Guidance On The Content Of Premarket Notification [510(k)] Submissions For Medical Devices With Sharps Injury Prevention Features, dated March 1995" and "various recognized standards."
- In-house test protocols: For evaluating various performance aspects of the device.
8. Sample Size for the Training Set:
This section is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI models. The development process would have involved design, prototyping, and iterative testing, but not a formally defined "training set" like in AI.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the same reasons as point 8. The development relied on established engineering principles, design specifications, and recognized safety and performance standards for medical devices.
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Merit Medical Systems, Inc. Majestik® Shielded Angiography Needle PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
OCT 1 1 2002
Name of Medical Device:
Classification Name: Common/Usual Name: Trade/Proprietary Name: Needle, Angiographic Angiography Needle Maiestik Shielded Angiography Needle
Device Classification:
Panel: Class: Product Code: Regulation Number:
Cardiovascular II 74 HAO 21 CFR 870.1390
Predicate Devices: Predicate 1
Device/Trade/Proprietary Name: Common/Usual Name: Classification Name:
Classification Panel: Regulatory Status:
Predicate 2
Device/Trade/Proprietary Name: Common/Usual Name: Classification Name:
Classification Panel: Regulatory Status:
Predicate 3
Device/Trade/Proprietary Name: Common/Usual Name: Classification Name:
Classification Panel: Regulatory Status:
Majestik® Angiography Needle Angiography Needle
Needle, Angiographic 21 CFR 870.1390 Cardiovascular Legally Marketed pre-Amendment
Axia RSN™ Guidewire Introducer Safety Needle Guidewire Introducer Needle Catheter Introducer 21 CFR 870.1340 Cardiovascular Legally Marketed via K011085
B-D SafetyGlide™ Shielding IM Injection Needle Hypodermic Needle Hypodermic Single Lumen Needle 21 CFR 880.5570 General Hospital Legally Marketed via K951254
Device Description:
The Merit Majestik Shielded Angiography Needle is a safety-engineered angiography needle that is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates an integral, user-activated needle shield (safety feature) that is activated once a conventional vessel puncture procedure has concluded. The Majestik Shielded Angiography Needle will provide clinicians with a safety version of the legally marketed pre-amendment Majestik Angiography Needle (or equivalent) currently used during Cardiology and Radiology procedures.
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Merit Medical Systems, Inc. Maiestik® Shielded Angiography Needle PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
The Majestik Shielded Angiography Needle incorporates a clear standard female luer locking connector for immediate bleedback visualization and is color coded for needle gauge identification. A one-piece, color coded folding needle shield, linked with "living hinges" is bonded to the female luer locking connector. The needle shield is color coded to match the luer connector for immediate needle gauge identification. The Majestik Shielded Angiography Needle is offered with the needle shield in two orientations: 1) oriented vertically to the ground bevel side of the needle; or 2) oriented 90 degrees to the ground bevel side of the needle. The Majestik Shielded Angiography Needle is a single use device supplied sterile and non-pyrogenic.
Intended Use:
The Merit Majestik Shielded Angiography Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices.
The Merit Majestik Shielded Angiography Needle incorporates a safety mechanism to minimize needlestick injuries when used to access the vascular system.
Summary of Characteristics in Relation to Predicate Devices:
Does the new device have the same indication statement:
Yes. The Majestik Shielded Angiography Needle has the same indication statement as the Axia RSN" Guidewire Introducer Safety Needle. The Majestik Shielded Angiography Needle has the same indications as the original pre-Amendment Majestik Angiography Needle without the needle shield.
Does the new device have the same technological characteristics, e.g., design, material, etc.?
Not in all respects. The Majestik Shielded Angiography Needle compares technologically to the predicate devices as follows.
Predicate 1 - Majestik Angiography Needle: The Majestik Shielded Angiography Needle is identical in all aspects to the Majestik Angiography Needle except that the subject device incorporates a needle shield safety feature.
Predicate 2 - Axia RSN" Guidewire Introducer Safety Needle: The Majestik Shielded Angiography Needle differs somewhat in design, materials, and methods of operation. The safety feature retracts the needle within an open-ended sheath when the safety feature activation button is pushed.
Predicate 3 - B-D SafetyGlide™ Shielding IM Injection Needle: The Majestik Shielded Angiography Needle employs similar method of operation, design, and materials when compared to the B-D device. Both incorporate a folding needle shield which, when activated by the user, snaps into place covering the needle tip.
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Merit Medical Systems. Inc. Majestik® Shielded Angiography Needle PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
Could the new characteristics affect safety or effectiveness?
Yes. The addition of a needle shield to the original Majestik Angiography Needle could affect the safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. The safety and effectiveness questions are the same for all needles of this type.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The FDA's Supplementary Guidance On The Content Of Premarket Notification [510(k)] Submissions For Medical Devices With Sharps Injury Prevention Features, dated March 1995, and various recognized standards as well as in-house test protocols were used to evaluate the device's performance.
Are performance data available to assess effects of the new characteristics?
Yes. Bench and simulated use tests were conducted according to the above referenced guidance document recommendations, as well as in accordance with in-house protocols. The results of testing were compared to the predicate devices where appropriate.
Those tests applicable to the type of safety device and safety features of the Majestik Shielded Angiography Needle per the Supplementary Guidance On The Content Of Premarket Notification [510(k)] Submissions For Medical Devices With Sharps Injurv Prevention Features were performed as follows.
- Dimensions -
- -Strength of bonds and hinges
- Force to activate the safety feature -
- Puncture resistance of shield or sheath: the force to failure (puncture) -
- Biocompatibility -
- Simulated Clinical Use -
The Majestik Shielded Angiography Needle met all acceptance criteria of the tests performed.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrated that the Majestik Shielded Angiography Needles are substantially equivalent to the predicate devices and/or met acceptance criteria as defined in testing protocols. The risks associated with use of the Majestik Shielded Angiography Needle were found acceptable when evaluated by FMEA.
CONCLUSION:
The Majestik Shielded Angiography Needle met all acceptance criteria of the testing performed and, based upon FDA's substantial equivalence determination decision tree, is substantially equivalent to the predicate devices referenced in this summary.
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Image /page/3/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 image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Merit Medical Systems, Inc. Ms. Stephanie A. Erskine Regulatory Affairs Director 1600 West Merit Parkway South Jordan, UT 84095
Re: K022117
Trade Name: Majestik® Shielded Angiography Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: II Product Code: DRC Dated: September 25, 2002 Received: September 26, 2002
Dear Ms. Erskine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Stephanie A. Erskine
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Daia Tell
Bram Zuckerman, M.D.
Sram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Merit Medical Systems, Inc. Majestik® Shielded Angiography Needle PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL
Section 7
Statement of Indications for Use
510(k) Number (if known): K022117
Device Name: Majestik Shielded Angiography Needle
Indications for Use:
- The Merit Majestik® Shielded Angiography Needle is used for providing a ● puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates a safety mechanism to help minimize needléstick injuries after use.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K22117
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.