(290 days)
Not Found
No
The device description focuses on the physical characteristics of the needle and its echogenic treatment for improved ultrasound visibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the transient delivery of anesthetics to provide regional analgesia, which falls under therapeutic use.
No
The device is a needle/cannula for delivering anesthetics, enhanced for ultrasound visibility, rather than for diagnosing conditions. Its purpose is therapeutic delivery and facilitating catheter placement, not diagnostic assessment.
No
The device description clearly states it is a physical needle made of stainless steel with a Luer locking hub and an echogenic treatment. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a needle/cannula used to physically deliver anesthetic agents into the body for regional analgesia or catheter placement. It is a surgical/procedural tool, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states the delivery of anesthetics and facilitation of catheter placement, which are therapeutic or procedural actions, not diagnostic ones.
- Device Description: The description focuses on the physical characteristics of the needle and its enhancement for ultrasound visibility, which aids in the placement of the needle within the body, not in analyzing a biological sample.
Therefore, the Spectra Sonic Block Needles are considered a medical device used in procedures, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The cannulas/needles for anesthesia and analgesia enhanced for ultrasound visibility - Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter.
Product codes
BSP
Device Description
The Spectra Sonic Block Needles consist of a stainless steel needle and a clear standard female Luer locking hub. The needles are available in a range of needle tip configuration, gauges and lengths to match the end-user need. These needles have an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Sonic Block Needles will be marketed as sterile, non-pyrogenic, and single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
May be used during all anesthetic and analgesic procedures according to the physician's indication.
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Used in Hospital, Clinics, Research Centers, Ambulance, and others
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the needles has been conducted in accordance with the FDA "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995. The submission devices meet the requirements. The battery of tests included the following: Cytotoxicity, System Toxicity, Hemocompatibility, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogen Test.
Sterilization and shelf Life: The requirements of ANSI/AAMI/ISO 11135-1:2014 Sterilization of Health Care Products- Ethylene Oxide-Part 1: Requirements for the development, Validation and Routine Control of the Sterilization process for Medical Devices have been met.
Non-Pyrogenic Testing: The requirements of ANSI/AAMI ST72: 2011 have been met.
Other performance tests: Physical tests were performed to ensure that the Spectra Sonic Block Needles had standard ISO Luer hubs with applicable Luer testing in accordance with ISO 594. Needle bond strength tests in accordance with ISO 7864, with hubs were also conducted. All the testing for stiffness and breakage was performed under ISO 9626. The Spectra Medical Devices, Inc. Sonic Block Needles passed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Spectra Medical Devices % James Wason Principal Maelor Group, Inc 7 Village Woods Dr Amherst, New Hampshire 03031
Re: K163292
Trade/Device Name: Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba, Spectra Sonic Block Crawford Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: August 7, 2017 Received: August 9, 2017
Dear James Wason:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,
Tara A. Ryan -S
for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163292
Device Name
Spectra Sonic Block Tuoly, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles
Indications for Use (Describe)
The cannulas/needles for anesthesia and analgesia enhanced for ultrasound visibility - Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter.
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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Image /page/3/Picture/1 description: The image shows the logo for Spectra Leading Edge Medical Devices. The logo features a globe with a rainbow spectrum across it. To the right of the globe is the word "SPECTRA" in large, bold, black letters. Underneath the word "SPECTRA" is the phrase "LEADING EDGE MEDICAL DEVICES" in smaller, black letters.
510(k) Summary for Spectra Sonic Block Needles
1. SPONSOR
Spectra Medical Devices, Inc. 260-H Fordham Road Wilmington, MA 01887
Contact Person: Agustin Turriza
Date Prepared: September 8, 2017
2. DEVICE NAME
- Proprietary Name: Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles Common/Usual Name: Anesthesia conduction needles/cannulas Classification Name: Needle, conduction, anesthetic (w/wo introducer) Classification Reference: 21 CFR 868.5150 Product Code: BSP
Regulatory Class: 2
3. PREDICATE DEVICES
Pajunk Medical Systems, K113207
4. DEVICE DESCRIPTION
The Spectra Sonic Block Needles consist of a stainless steel needle and a clear standard female Luer locking hub. The needles are available in a range of needle tip configuration, gauges and lengths to match the end-user need. These needles have an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Sonic Block Needles will be marketed as sterile, non-pyrogenic, and single use devices.
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Image /page/4/Picture/0 description: The image is a logo for Spectra, a company that specializes in leading-edge medical devices. The logo features a colorful globe on the left side, with the word "SPECTRA" in bold, black letters on the right. Below the word "SPECTRA" is the tagline "LEADING EDGE MEDICAL DEVICES" in smaller, black letters. The logo is simple, yet effective, and it conveys the company's focus on innovation and technology.
The needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles / cannulas may be used during all anesthesia and analgesia procedures according to the physician's indication.
Needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are standard needles /cannulas equipped with dimpled echogenic tip in order to significantly enhance ultrasound visibility. This surface technology allows for a variety of sizes. The inner diameter is not effect by the echogenic treatment. This feature completely encircles the tip of the needles / cannulas so all sides appear bright under ultrasound. In order to enhance ultrasound visibility, the needles / cannulas are equipped with a special dimpled pattern named Sonic Block dimples to the needles / cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.
Brand names of the original file as well as the corresponding brand names of the subject file are:
Predicate: Tuohy SONO Predicate: Quincke SONO Predicate: Crawford SONO Predicate Chiba SONO
Subject: Spectra Sonic Block Tuohy Subject: Spectra Sonic Block Quincke Subject: Spectra Sonic Block Crawford Subject: Spectra Sonic Block Chiba
The detailed discussion of substantial equivalence can be found in Section 12 of this submission.
Technological Characteristics:
Tip Specifications
The tips of the needles / cannulas covered by this 510(k) are identical to the tips of the original predicate devices submission: Tuohy tip, Beveled tip (which is synonymously used with Chiba tip and facetted tip), Crawford tip and Quincke tip.
Length
The length of the needles / cannulas subject to this 510(k) submission are identical to the lengths of the needles cannulas covered by the predicate device submission.
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Image /page/5/Picture/0 description: The image is a logo for Spectra Leading Edge Medical Devices. The logo features a globe with a rainbow spectrum of colors on the left side. To the right of the globe is the word "SPECTRA" in large, bold, black letters. Below the word "SPECTRA" is the phrase "LEADING EDGE MEDICAL DEVICES" in smaller, black letters.
Predicate
Subject
| Tuohy Sono: 20mm-180mm | Spectra Sonic Block Tuohy: 20mm-180mm |
|---|---|
| Quincke Sono: 20mm-180mm | Spectra Sonic Block Quincke: 20mm-180mm |
| Chiba Sono: 20mm-180mm | Spectra Sonic Block Chiba: 20mm-180mm |
| Crawford Sono: 20mm-180mm | Spectra Sonic Block Crawford: 20mm-180mm |
Diameters
The diameters of the needles /cannulas subject to this 510(k) submission are identical to the diameters of the cannulas covered by the predicate device submission.
| Predicate | Subject |
|---|---|
| Tuohy Sono: 16G-26G | Spectra Sonic Block Tuohy: 16G - 26G |
| Quincke Sono: 16G-26G | Spectra Sonic Block Quincke: 16G - 26G |
| Chiba Sono: 16G-26G | Spectra Sonic Block Chiba: 16G - 26G |
| Crawford Sono: 16G-26G | Spectra Sonic Block Crawford: 16G - 26G |
ട. INTENDED USE
The cannulas/needles for anesthesia and analgesia enchanced for ultrasound visibility -Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.
6. SUBSTANTIAL EQUIVALENCE
The Spectra Medical Devices, Inc. Sonic Block needles: Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba and Sonic Block Crawford are substantially equivalent to Pajunk GmbH, Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono.
The above devices were granted marketing clearance by the FDA on February 29, 2012, under 510(k) number K113207.
The differences in the subject and predicate device are minimal of the submission.These diffrences do not raise any different questions of satety and effectiveness.
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| TOPIC | SPECTRA DEVICE | PAJUNK GmbH | SIMILARITIES | DIFFERENCES |
|---|---|---|---|---|
| 510(K) Number | K163292 | K113207 | N/A | N/A |
| Regulation Number | 21 CFR 868.5150 | 21 CFR 868.5150 | Same | None |
| Product Classification | BSP | BSP | Same | None |
| Class | II | II | Same | None |
| Indications for use | The cannulas/needles for anesthesia and analgesia enchanced for ultrasound visibility -Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter. | The cannula/needles for anesthesia and analgesia enhanced for ultrasound visibility - Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter. | The Indications for Use are basically the same, in that they are both conduction needles intended to administer regional anesthesia and have a echogenic surface feature to enhance visibility under ultrasound imaging. The Spectra device references the intent to mate with a Luer Lock or Slip connector. | None |
| Target population | Adult and Pediatric | Adult and Pediatric | Same | None |
| Design | Single Use Disposable Device | Single Use Disposable Device | Same | None |
| Design – Hub & Needle Protector | Echogenic Anesthesia Conduction Needles with a molded Square Hubs and a Stainless Steel Needle. The needle protector is an extracted tube. | Echogenic Anesthesia Conduction Needles with a molded Square Hub and a Stainless Steel Needle. The needle protector is an extruded tube. | Same | None |
| Design - Needle Bevels | Sonic Block Tuohy – 8° | |||
| Sonic Block Crawford - 45° | ||||
| Sonic Block Quincke - 16° | ||||
| Sonic Block Chiba - 30° | Tuohy Sono - 8° | |||
| Crawford Sono - 45° | ||||
| Quincke Sono - 16° | ||||
| Chiba Sono - 30° | Same | None | ||
| Design - Needle Gauge Size | Sonic Block Tuohy: 16G - 26G | |||
| Sonic Block Crawford: 16G - 26G | ||||
| Sonic Block Quincke: 16G - 26G | Tuohy Sono: 16G – 26G | |||
| Crawford Sono: 16G – 26G | ||||
| Quincke Sono: 16G – 26G | ||||
| Chiba Sono: 16G – 26G | Same | None | ||
| Sonic Block Chiba: 16G – 26G | ||||
| Design - Needle Length | Sonic Block Tuohy: 20 – | |||
| 180mm | ||||
| Sonic Block Crawford: 20- | ||||
| 180mm | ||||
| Sonic Block Quincke: 20- | ||||
| 180mm | ||||
| Sonic Block Chiba: 20-180mm | Tuohy Sono: 20-180mm | |||
| Crawford Sono: 20-180mm | ||||
| Quincke Sono: 20-180mm | ||||
| Chiba Sono: 20-180mm | Same | None | ||
| Design – Echogenic | ||||
| Treatment of Needle Tip | Echogenic Surface Treatment | |||
| [dimpling] of Needle Tip for | ||||
| Ultrasound Visualization | Echogenic Surface Treatment | |||
| (CornerStone) | Similar; both are functional | Echogenic Treatment | ||
| methods are different and | ||||
| shape of reflective surface is | ||||
| different. | ||||
| Life Cycle | 5 Years | 5 Years | Same | None |
| Materials | Cannula = 304 Stainless Steel | |||
| Square Hub = Polycarbonate | ||||
| Protector = LDPE | ||||
| Adhesive = Epoxy | ||||
| Same for all (4) Needles | Cannula = 304 Stainless Steel | |||
| Square Hub = Polycarbonate | ||||
| Protector = LDPE | ||||
| Adhesive = Epoxy | ||||
| Same for all (4) Needles | Equivalent Materials of | |||
| Construction | None | |||
| Performance | Hub/Cannula Tensile Strength | |||
| Luer Taper | ||||
| Separation from Luer | Hub/Cannula Tensile Strength | |||
| Luer Taper | ||||
| Separation from Luer | Equivalent | None | ||
| Sterility | Supplied Packaged Sterile | Supplied Packaged Sterile | Same | None |
| Sterilization Method(s) | EO (Ethylene Oxide) | EO (Ethylene Oxide) | Same | None |
| Chemical safety | Device does not pose a | |||
| chemical hazard and is | ||||
| compatible with chemicals | ||||
| commonly used in the areas | ||||
| designated for use. | Assumed; Device does not | |||
| pose a chemical hazard and is | ||||
| compatible with chemicals | ||||
| commonly used in the areas | ||||
| designated for use. | Same | None | ||
| Anatomical Sites | May be used during all | |||
| anesthetic and analgesic | ||||
| procedures according to the | ||||
| physician's indication. | May be used during all | |||
| anesthetic and analgesic | ||||
| procedures according to the | ||||
| physician's indication. | Same | None | ||
| Energy used and /or delivered | No Energy used or delivered | |||
| by the Device | No Energy used or delivered | |||
| by the Device | Same | None | ||
| Compatibility with | ||||
| environment and other | ||||
| devices | Device does not contain any | |||
| materials considered to be | ||||
| dangerous to the | ||||
| environment. | Assumed; Device does not | |||
| contain any materials | ||||
| considered to be dangerous | ||||
| to the environment. | Same | None | ||
| Device is designed to connect | ||||
| to a piston syringe (L/S and | ||||
| L/L) or extension set with a | ||||
| male luer connector. | Device is designed to connect | |||
| to a piston syringe (L/S and | ||||
| L/L) or extension set with a | ||||
| male luer connector. | ||||
| Where used: hospital, home, | ||||
| ambulance, etc. | Used in Hospital, Clinics, | |||
| Research Centers, | ||||
| Ambulance, and others | Used in Hospital, Clinics, | |||
| Research Centers, | ||||
| Ambulance, and others | Same | None | ||
| Thermal safety | Device does not contain a | |||
| thermal source | Device does not contain a | |||
| thermal source | Same | None | ||
| Radiation safety | Device does not admit any | |||
| form of radiation | Device does not admit any | |||
| form of radiation | Same | None | ||
| Performance testing | Hub/Cannula Tensile Strength | Hub/Cannula Tensile Strength | Same | None |
| Electrical safety | Device does not contain an | |||
| electrical source or connect to | ||||
| an electrical source | Device does not contain an | |||
| electrical source or connect to | ||||
| an electrical source | Same | None | ||
| Biocompatibility | Biocompatibility Testing has | |||
| been conducted for each | ||||
| product configuration with | ||||
| test results confirming | ||||
| compliance with ISO 10993-1 | ||||
| requirements. | Assumed; Biocompatibility | |||
| Testing has been conducted | ||||
| per ISO 10993-1 and included | ||||
| with 510(K) Submission to | ||||
| FDA based on statement in | ||||
| Patent. | Same | None | ||
| Mechanical safety | Device does not include a | |||
| separate safety feature and | ||||
| does not claim it is a safety | ||||
| device. | Device does not include a | |||
| separate safety feature and | ||||
| does not claim it is a safety | ||||
| device. | Same | None |
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Image /page/9/Picture/0 description: The image shows the logo for Spectra Leading Edge Medical Devices. The logo features a colorful globe on the left side, with the word "SPECTRA" in large, bold letters to the right. Below the word "SPECTRA" is the phrase "LEADING EDGE MEDICAL DEVICES" in smaller letters.
7. PERFORMANCE TESTING
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the needles has been conducted in accordance with the FDA "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995. The submission devices meet the requirements. The battery of tests included the following:
- Cytotoxicity ●
- System Toxicity ●
- Hemocompatibility ●
- Sensitization ●
- Irritation or Intracutaneous Reactivity
- Material Mediated Pyrogen Test
Sterilization and shelf Life
The requirements of ANSI/AAMI/ISO 11135-1:2014 Sterilization of Health Care Products- Ethylene Oxide-Part 1: Requirements for the development, Validation and Routine Control of the Sterilization process for Medical Devices have been met. The information and data is shown in Section 14.
Non-Pyrogenic Testing
The requirements of ANSI/AAMI ST72: 2011 have been met. The information is shown in Section 14.
Other performance tests
Physical tests were performed to ensure that the Spectra Sonic Block Needles had standard ISO Luer hubs with applicable Luer testing in accordance with ISO 594. Needle bond strength tests in accordance with ISO 7864, with hubs were also conducted. All the testing for stiffness and breakage was performed under ISO 9626. The Spectra Medical Devices, Inc. Sonic Block Needles passed all tests.
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Image /page/10/Picture/0 description: The image shows the text "K163292" in a simple, sans-serif font. The text is black and appears to be against a white background. The numbers and letters are evenly spaced and clearly legible.
Image /page/10/Picture/1 description: The image contains the logo for "SPECTRA LEADING EDGE MEDICAL DEVICES". The logo features a globe with a rainbow spectrum of colors on the left side. To the right of the globe is the word "SPECTRA" in large, bold, black letters. Underneath the word "SPECTRA" is the phrase "LEADING EDGE MEDICAL DEVICES" in smaller, black letters.
Conclusion
This 510(k) does not raise any different questions of safety and effectiveness or a new intended use since clearance is only being requested for the same technological characteristics and intended use, which has been previously cleared by the FDA in the predicate devices.
The Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford needles have been compared to the noted predicate needles. This submission demonstrates that the Spectra Medical Devices, Inc. needles are substantially equivalent to the predicate devices.