(94 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI/ML terms or functionalities.
No.
The device is used to introduce and place guidewires in vascular procedures, which are interventional steps rather than therapeutic outcomes for a condition. Its function is procedural, not curative or palliative.
No
This device is designed for the introduction and placement of guidewires in vascular procedures, which is an interventional/surgical function, not a diagnostic one. Its purpose is to facilitate access for other procedures, not to identify a disease or condition.
No
The device description explicitly states it consists of a stainless steel needle and a Luer lock hub, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Spectra Guidewire Introducer Needle Function: The description clearly states the device is used for the percutaneous introduction and placement of guidewires in vascular procedures. This is a surgical/interventional procedure performed on the patient's body, not a test performed on a specimen taken from the body.
- Intended Use: The intended use is to facilitate the placement of guidewires within the vascular system, which is a direct intervention on the patient.
- Device Description: The description focuses on the physical characteristics of a needle designed for insertion into the body.
The Spectra Guidewire Introducer Needle is a surgical/interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.
Product codes
DWS, DYB
Device Description
The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.
Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols. Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Teleflex Medical Introducer Needle (K851140), Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040)
Reference Device(s)
Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The Spectra Guidewire Introducer Needle is substantially equivalent design, materials, and method of use. The basic fundamental scientific technology of the device has not changed.
Could the new characteristics affect safety or effectiveness? No.
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.
Do performance data demonstrate equivalence? Yes. Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices.
CONCLUSION
The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing. This testing demonstrated that the Spectra Guidewire Introducer Needle is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices Teleflex Medical Introducer Needle (K851140), and Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040).
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SPECTRA MEDICAL DEVICE, INC.
510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
21 CFR 870.4500 Regulation Number: Proprietary Name: Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040) Regulation Name: Instruments, Surgical, Cardiovascular Common/Usual Name: Guidewire Introducer Needle Classification Panel: Cardiovascular Regulatory Class: Class II Product Code: DWS Regulation Number: 21 CFR 870.4500
DEVICE DESCRIPTION:
The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.
Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.
INTENDED USE:
The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
INDICATIONS FOR USE:
The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.
Does the new device have the same indication statements? Yes.
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KØ82580Ø
SPECTRA MEDICAL DEVICE, INC.
510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for Spectra GUIDEWIRE INTRODUCER NEEDLE
SUBMITTER:
Spectra Medical Devices, Inc. 260-H Fordham Road Wilmington, Massachusetts, 01887
ESTABLISHMENT REGISTRATION NUMBER: 1224960
CONTACT:
Agustin Turriza QA/RA Manager Telephone: (978) 657-0889 Fax: (978) 657-4339 Email: aturriza@SpectraMedical.com
DATE PREPARED:
August 21, 2008
NAME OF MEDICAL DEVICE:
Proprietary Name: Regulation Name: Common/Usual Name:
Spectra Guidewire Introducer Needle Introducer, Catheter Guidewire Introducer Needle
DEVICE CLASSIFICATION:
Classification Panel: Regulatory Class: Product Code: Regulation Number: Cardiovascular Class II DYB 21 CFR 870.1340
PREDICATE DEVICES:
Proprietary Name: Regulation Name: Common/Usual Name: Classification Panel: Regulatory Class: Product Code:
Teleflex Medical Introducer Needle (K851140) Instruments, Surgical, Cardiovascular Guidewire Introducer Needle Cardiovascular Class II DWS
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 8 2008
Mr. Agustin Turriza Ouality Assurance/Regulatory Affairs Manager Spectra Medical Devices, Incorporated 260-H Fordham Road Wilmington, Massachusetts 01887
Re: K082580
Trade/Device Name: Spectra Guidewire Introducer Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: August 27, 2008 Received: September 9, 2008
Dear Mr. Turriza:
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.
4
Page 2 - Mr. Turriza
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyte H. Michau us
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SPECTRA MEDICAL DEVICE, INC.
510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
Indications For Use
510(k) Number (if known):
Device Name: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
Indications For Use:
The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 482580