The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or an extension set.

Device Description

The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle consists of a stainless steel needle and a clear or colored (translucent) standard female Luer lock square or round Hub locking connector for rapid (flashback) visualization. The stainless steel needles are available with and without an echogenic feature (i.e. mechanical dimpling treatment to the needle point surface), and with or without lubrication. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need (16 to 30 gauges).

AI/ML Overview

The provided document is a 510(k) summary for a medical device (SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance in the context of AI/ML or diagnostic accuracy.

Therefore, many of the requested categories for AI/ML study details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific performance metrics (like sensitivity, specificity, AUC), are not applicable or available in this document. This document describes a traditional medical device, not an AI/ML system.

However, I can extract information related to the performance data presented to support the substantial equivalence claim.

Here's the information derived from the document:

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance, but rather lists the mechanical and biocompatibility tests performed and concludes that the device "exhibited comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable."

Test Category	Specific Tests Performed	Reported Device Performance
Mechanical Testing	- Bond strength of hub and cannula- ISO 594-1 (Luer Fittings)- ISO 7864:11 (Sterile hypodermic needles)- Luer compatibility- Hub and Needle Strength- Penetration Force	"Exhibited comparable mechanical and functional characteristics to the predicate device." The device's performance in these tests was deemed acceptable and comparable to the predicate device, supporting substantial equivalence.
Biocompatibility Testing	- ISO 10993-5: Cytotoxicity Study Using the ISO Elution Method- ISO 10993-4: In Vitro Hemolysis Study (Modified ASTM-Extraction Method)- ISO 10993-11: USP and ISO Systemic Toxicity Study - Extracted- ISO 10993-10: ISO Intracutaneous Study - Extract- ISO 10993-10: ISO Maximization Sensitization Study - Extract	"Biocompatible acceptable." The product contact materials were "well characterized chemically and physically," and test results confirmed "compliance with ISO 10993 requirements."
Sterility	"Supplied Packaged Sterile"	The device is supplied as sterile. (Sterilization method: EO (Ethylene Oxide))

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the following performance data was provided" without specifying the number of units tested for each mechanical or biocompatibility assessment.
Data Provenance: Not specified. This is a submission to the FDA for a new device, so the testing would have been conducted by the manufacturer or their contracted labs. No information about country of origin of data (e.g., patient data) is relevant here as this is a physical device. The studies are prospective in the sense that they were conducted for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable for this type of medical device submission. Ground truth in the context of diagnostic accuracy or AI/ML is not relevant here. The "truth" for mechanical and biocompatibility tests is based on the results of validated laboratory methods and adherence to international standards (ISO, ASTM).

4. Adjudication method for the test set

This is not applicable. No human interpretation or adjudication common in AI/ML validation studies is mentioned. The assessment is based on objective laboratory measurements against established standards.

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

This is not applicable. The device is a physical anesthesia needle, not an AI system. No MRMC study was conducted.

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

This is not applicable. The device is a physical anesthesia needle, not an algorithm.

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

The "ground truth" for the performance data in this context refers to established international standards and validated laboratory test methods (e.g., ISO 594-1, ISO 7864:11, ISO 10993 series). The device's characteristics were measured against these standards to demonstrate compliance and comparability to the predicate.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.

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

This is not applicable. There is no "training set" or corresponding ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2016

Spectra Medical Devices, Inc. % Tanya O'Brien Clinical Affairs Specialist AJW Technology Consultants, Inc. 445 Apollo Beach Blvd Apollo Beach, Florida 33572

Re: K151069

Trade/Device Name: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: November 23, 2015 Received: December 8, 2015

Dear Ms. O'Brien:

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

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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 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/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 yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K151069

Device Name

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle

Indications for Use (Describe)

The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain the echnogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or extension set.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

(as required by 807.92)

-SUBMITTER

Spectra Medical Devices, Inc. 260 F/H Fordham Road Wilmington, MA 01887

Phone: 757-220-8917 Fax: 757-220-8919

Contact Person: Scott Henderson Date Prepared: March 26, 2015

REGULATORY CORRESPONDENT

AJW Technology Consultants, Inc. 445 Apollo Beach, Blvd. Apollo Beach, FL 33572

Contact Person: Tanya O'Brien Email: tmobrien@ajwtech.com

Phone: 813-645-2855 x102 Fax: 813-645-2856

11. DEVICE

Name of Device: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle Common or Usual Name: Conduction Needle Classification Name: Needle, Anesthesia Conduction Device Panel: Anesthesiology Regulatory Class: 2 Product Code: BSP Contact Type: Limited Exposure Device

lll. PREDICATE DEVICE

● Havel's Inc. - K063380 ECHOSTIM FACIT TIP These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

V. INIDCATIONS FOR USE

VI. COMPMARISOIN OF TECHNOLIGICAL CHARACTERISTICS IWHT THE PREDICATE DEVICE

To inject fluids (drug solutions), or withdraw fluids from parts of the body below the surface of the skin is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter. At a high level, the subject and predicate devices are based on the following same technological characteristics:

. Design
. Materials of the needle
Sterility
. No thermal source
Indications for use ●

The following technological differences exist between the subject and predicate devices:

. Additional or different sizes of needles are offered
Some additional/different materials are used for the Spectra hub designs
Physical dimensions
VII. DEVICE COMPARISON CHART See Appendix A

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VIII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination.

Mechanical Testing

Bond strength of hub and cannula
ISO 594-1
ISO 7864:11 ●
Luer compatibility ●
Hub and Needle Strength

BIOCOMPATIBILITY TESTING וא.

The product contact materials utilized in the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles have been well characterized chemically and physically. The following table indicates the individual biocompatibility tests performed on the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles.

Test	Description
ISO 10993-5	Cytotoxicity Study Using the ISO Elution Method
ISO 10993-4	In Vitro Hemolysis Study (Modified ASTM-Extraction Method)
ISO 10993-11	USP and ISO Systemic Toxicity Study - Extracted
ISO 10993-10	ISO Intracutaneous Study - Extract
ISO 10993-10	ISO Maximization Sensitization Study - Extract

X. CONCLUSIONS

The testing completed demonstrates that the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles have exhibited comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable. Based on these characteristics, the Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needles, ARE substantially equivalent to the predicate device in addition to being intended for the same uses.

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APPENDIX A

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SPECTRA DEVICE	HAVEL'S	SIMILARITIES	DIFFERENCES
Pending21 CFR 868.5150BSP	K06338021 CFR 868.5150BSP	N/A	N/A
II	II	Same	None
The SPECTRA DisposableSingle Lumen EchogenicInjection AnesthesiaConduction Needle isintended for use in injecting asingle dose of local anestheticor analgesic into a patient forregional anesthesia or paintherapy with the echogenicreflective pattern providingvisualization of the needle tipusing Ultrasound Imaging.The needles are intended tomate with the maleconnector of a Luer Lock orLuer Slip Syringe or anextension set.	Havel's Electrically insulatedanesthesia conductionneedles are used to puncturethe tissue in order to gainentry and locally injectanesthetics to induce regionalanesthesia. An electricalstimulus may be applied tothe needle via a cable andconnector to assist thephysician to pinpoint the areaof application.	SameThe Indications for Use arebasically the same, in thatthey are both conductionneedles intended toadminister regionalanesthesia, and both are usedas a non-insulated needle.	None for Non-InsulatedHavel's Needle Configuration
Adult and PediatricSingle Use Disposable DeviceEchogenic InjectionAnesthesia ConductionNeedle with Standard RoundLuer Style Hub or SquareHubs and a Stainless SteelNeedle. The needle protectoris an extracted tube or amolded protector. Thesquare clear hub has acolored printed bevelindicator and the round luerhub is colored with no bevelindicator.	Adult and PediatricSingle Use Disposable DeviceEchogenic InjectionAnesthesia ConductionNeedle with a molded SquareHub and a Stainless SteelNeedle. The needle protectoris an extruded tube. The Sq.needle hub has a coloredmolded insert as a bevelindicator.	SameThe molded Hub for bothproducts is functionallyequivalent, as are thestainless steel needle andneedle protector.	NoneThe Havel's Hub Assembly hasa metal Bushing and is Glued;the Spectra Sq. Hub Assemblyis over molded and the RoundLuer Hub Assembly is glued.The Havel's Hub has a moldedbevel indicator; the Spectrahub has a printed bevelindicator. The Havel's needlehas depth marks on theneedle and the Spectraneedles do not.
B = 17° & C = 30°21G to 25G; 2.0" to 6.0"	B = 17° & C= 30°21G to 22G; 2.0" to 6.00"	SameSimilar Gauge Range	NoneSpectra has a 25G Needle

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Design - Echogenic Treatment of Needle Tip	Echogenic Treatment [dimpling] of Needle Tip for Ultrasound Visualization	Echogenic Treatment [4 x 4 Corner Cube indentations] of Needle Tip for Ultrasound Visualization	Similar; both are functional	Echogenic Treatment methods are different and shape of reflective surface is different.
Materials	Cannula = 304 Stainless SteelRound Hub = PolypropyleneSquare Hub = K-ResinProtector = LDPE / Polypropylene (Molded)Lubrication = Silicone	Cannula = 304 Stainless SteelSquare Hub = N/A (PP)Protector = N/A	Equivalent Materials of Construction	None
Performance	Hub/Cannula Tensile StrengthPenetration ForceLuer Taper	Hub/Cannula Tensile StrengthLuer TaperSeparation from Luer	Same	None
Sterility	Separation from Luer	Supplied Packaged Sterile	Same	None
Sterilization Method(s)	Supplied Packaged Sterile	EO (Ethylene Oxide)	Same	None
Chemical safety	EO (Ethylene Oxide)	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	Device does not pose a chemical hazard and is compatible with chemicals commonly used in the areas designated for use.	Various, including: Arm, Hand, Neck, Shoulder, Groin, Buttock, Leg, Knee, Foot, etc.	Same	None
Energy used and /or delivered	Various, including: Arm, Hand, Neck, Shoulder, Groin, Buttock, Leg, Knee, Foot, etc.	No Energy used or delivered by the Device	Same	None
Compatibility with environment and other devices	No Energy used or delivered by the Device	Assumed; Device does not contain any materials considered to be dangerous to the environment.	Same	None
Where used: hospital, home, ambulance, etc.	Device does not contain any materials considered to be dangerous to the environment.	Device is designed to connect to a piston syringe (L/S and L/L) or extension set with a male luer connector.	Same	None
Thermal safety	Device is designed to connect to a piston syringe (L/S and L/L) or extension set with a male luer connector.	Used in Hospital, Clinics, Research Centers, Ambulance, and othersDevice does not contain a thermal source	Same	None

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Radiation safety	Device does not admit anyform of radiation	Device does not admit anyform of radiation	Same	None
Performance testing	Hub/Cannula Tensile StrengthPenetration Force	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 10993requirements.	Assumed; BiocompatibilityTesting has been conductedand included with 510(K)Submission to FDA.	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

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).