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.

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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically anesthesia conduction needles (Spectra Sonic Block Tuohy, Quincke, Chiba, and Crawford needles). It aims to demonstrate substantial equivalence to a predicate device (Pajunk Medical Systems, K113207).

The information provided does not describe an AI medical device or a study involving AI assistance for human readers. Instead, it focuses on the physical and performance characteristics of a traditional medical device (needles) to prove its substantial equivalence to an already marketed device. Therefore, many of the requested items related to AI system acceptance criteria, MRMC studies, standalone algorithm performance, and ground truth establishment for AI training/test sets are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the studies performed to prove it meets those criteria, within the context of a traditional medical device submission.

Here's the breakdown of the available information:

Device: Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba, and Spectra Sonic Block Crawford Needles

Type of Device: Anesthesia Conduction Needles (Class II, Product Code: BSP)

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formalized "acceptance criteria" table in the way one might typically see for an AI device (e.g., minimum sensitivity, PPV). Instead, it demonstrates performance by meeting established medical device standards and showing equivalence to a predicate device. The performance data effectively serve as proof of meeting implicit acceptance criteria related to safety and efficacy for this type of device.

Acceptance Criteria (Implied)	Reported Device Performance (as demonstrated by testing/comparison)
Biocompatibility	Met requirements of FDA "Use of International Standard ISO 10993" standards. Battery of tests included: Cytotoxicity, System Toxicity, Hemocompatibility, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogen Test.
Sterility & Shelf Life	Met requirements of ANSI/AAMI/ISO 11135-1:2014 for Ethylene Oxide sterilization. Demonstrated 5-year life cycle (same as predicate).
Non-Pyrogenicity	Met requirements of ANSI/AAMI ST72: 2011.
Mechanical Performance (Physical Tests)	Passed all tests for: - Standard ISO Luer hubs (in accordance with ISO 594)- Needle bond strength (in accordance with ISO 7864)- Stiffness and breakage (in accordance with ISO 9626)
Material Compatibility & Safety	Cannula: 304 Stainless Steel (Same as predicate)Square Hub: Polycarbonate (Same as predicate)Protector: LDPE (Same as predicate)Adhesive: Epoxy (Same as predicate)Claims: Does not pose a chemical hazard, device does not contain a thermal source, device does not admit any form of radiation, device does not contain an electrical source.
Dimensional Specifications	Tip Configurations: Tuohy, Beveled (Chiba & Facetted), Crawford, Quincke (Identical to predicate)Lengths: 20mm-180mm for all types (Identical to predicate)Diameters (Gauges): 16G-26G for all types (Identical to predicate)Needle Bevels: Tuohy (8°), Crawford (45°), Quincke (16°), Chiba (30°) (Identical to predicate)
Intended Use	"Intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter." (Substantially similar to predicate).
Echogenicity (Ultrasound Visibility)	Enhanced for ultrasound visibility using a "dimpled echogenic tip" named "Sonic Block dimples" designed to optimally reflect ultrasonic waves. (Different method from predicate's "CornerStone" but functionally similar/improved).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes performance testing for a physical medical device (needles), not a machine learning model's test set. Therefore, "sample size" refers to the number of needles or materials tested according to various ISO and AAMI standards. The exact number of samples for each specific test (e.g., how many needles for bond strength, how many material samples for biocompatibility) is not detailed in this summary. It states that "The Spectra Medical Devices, Inc. Sonic Block Needles passed all tests."

Data Provenance: Not applicable in the context of clinical data for an AI model. The tests are laboratory-based performance validations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device (needles) and its performance against engineering and biocompatibility standards, not an AI model requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is for assessing clinical performance in AI, not for physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a needle, not an AI system. There is no human reader assistance component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable to this type of device submission. The "ground truth" for this device's performance is established by compliance with recognized international standards (ISO, AAMI) for mechanical, biological, and sterility properties. For example, the "ground truth" for bond strength is the force required to meet the ISO 7864 standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set for an AI model, there's no ground truth for it.

Summary

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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

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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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.

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 - 26GSonic Block Crawford: 16G - 26GSonic Block Quincke: 16G - 26G	Tuohy Sono: 16G – 26GCrawford Sono: 16G – 26GQuincke Sono: 16G – 26GChiba Sono: 16G – 26G	Same	None
	Sonic Block Chiba: 16G – 26G
Design - Needle Length	Sonic Block Tuohy: 20 –180mmSonic Block Crawford: 20-180mmSonic Block Quincke: 20-180mmSonic Block Chiba: 20-180mm	Tuohy Sono: 20-180mmCrawford Sono: 20-180mmQuincke Sono: 20-180mmChiba Sono: 20-180mm	Same	None
Design – EchogenicTreatment of Needle Tip	Echogenic Surface Treatment[dimpling] of Needle Tip forUltrasound Visualization	Echogenic Surface Treatment(CornerStone)	Similar; both are functional	Echogenic Treatmentmethods are different andshape of reflective surface isdifferent.
Life Cycle	5 Years	5 Years	Same	None
Materials	Cannula = 304 Stainless SteelSquare Hub = PolycarbonateProtector = LDPEAdhesive = EpoxySame for all (4) Needles	Cannula = 304 Stainless SteelSquare Hub = PolycarbonateProtector = LDPEAdhesive = EpoxySame for all (4) Needles	Equivalent Materials ofConstruction	None
Performance	Hub/Cannula Tensile StrengthLuer TaperSeparation from Luer	Hub/Cannula Tensile StrengthLuer TaperSeparation 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 achemical hazard and iscompatible with chemicalscommonly used in the areasdesignated for use.	Assumed; Device does notpose a chemical hazard and iscompatible with chemicalscommonly used in the areasdesignated for use.	Same	None
Anatomical Sites	May be used during allanesthetic and analgesicprocedures according to thephysician's indication.	May be used during allanesthetic and analgesicprocedures according to thephysician's indication.	Same	None
Energy used and /or delivered	No Energy used or deliveredby the Device	No Energy used or deliveredby the Device	Same	None
Compatibility withenvironment and otherdevices	Device does not contain anymaterials considered to bedangerous to theenvironment.	Assumed; Device does notcontain any materialsconsidered to be dangerousto the environment.	Same	None

	Device is designed to connectto a piston syringe (L/S andL/L) or extension set with amale luer connector.	Device is designed to connectto a piston syringe (L/S andL/L) or extension set with amale 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 athermal source	Device does not contain athermal source	Same	None
Radiation safety	Device does not admit anyform of radiation	Device does not admit anyform of radiation	Same	None
Performance testing	Hub/Cannula Tensile Strength	Hub/Cannula Tensile Strength	Same	None
Electrical safety	Device does not contain anelectrical source or connect toan electrical source	Device does not contain anelectrical source or connect toan electrical source	Same	None
Biocompatibility	Biocompatibility Testing hasbeen conducted for eachproduct configuration withtest results confirmingcompliance with ISO 10993-1requirements.	Assumed; BiocompatibilityTesting has been conductedper ISO 10993-1 and includedwith 510(K) Submission toFDA based on statement inPatent.	Same	None
Mechanical safety	Device does not include aseparate safety feature anddoes not claim it is a safetydevice.	Device does not include aseparate safety feature anddoes not claim it is a safetydevice.	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.

Regulation Number and Section

§ 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).