Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and material properties of a needle, with no mention of AI or ML for image processing or any other function.

Therapeutic

Yes
The device is used for injecting anesthetics or analgesics for regional anesthesia or pain therapy, which are therapeutic applications.

Diagnostic

No

This device is an injection needle used for administering local anesthetics or analgesics, and its primary function is therapeutic delivery, not diagnosis. While it uses ultrasound for visualization, the visualization is to guide the injection, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical needle made of stainless steel with a hub, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for injecting local anesthetic or analgesic into a patient for regional anesthesia or pain therapy. This is a therapeutic procedure performed directly on the patient's body.
Device Description: The device is a needle designed for injection.
Lack of In Vitro Testing: The device is not used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing. The testing described is mechanical and biocompatibility testing related to the device's function and safety for use in the body.

IVD devices are specifically designed for testing biological samples in vitro (outside the living organism) to provide diagnostic information. This device is used in vivo (within the living organism) for a therapeutic purpose (delivering medication).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

BSP

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound Imaging

Anatomical Site

Various, including: Arm, Hand, Neck, Shoulder, Groin, Buttock, Leg, Knee, Foot, etc.

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)

Mechanical Testing

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

BIOCOMPATIBILITY TESTING

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063380

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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

1

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

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).

V. INIDCATIONS FOR USE

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.

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
Pending
21 CFR 868.5150
BSP	K063380
21 CFR 868.5150
BSP	N/A	N/A
II	II	Same	None
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.	Havel's Electrically insulated
anesthesia conduction
needles are used to puncture
the tissue in order to gain
entry and locally inject
anesthetics to induce regional
anesthesia. An electrical
stimulus may be applied to
the needle via a cable and
connector to assist the
physician to pinpoint the area
of application.	Same
The Indications for Use are
basically the same, in that
they are both conduction
needles intended to
administer regional
anesthesia, and both are used
as a non-insulated needle.	None for Non-Insulated
Havel's Needle Configuration
Adult and Pediatric
Single Use Disposable Device
Echogenic Injection
Anesthesia Conduction
Needle with Standard Round
Luer Style Hub or Square
Hubs and a Stainless Steel
Needle. The needle protector
is an extracted tube or a
molded protector. The
square clear hub has a
colored printed bevel
indicator and the round luer
hub is colored with no bevel
indicator.	Adult and Pediatric
Single Use Disposable Device
Echogenic Injection
Anesthesia Conduction
Needle with a molded Square
Hub and a Stainless Steel
Needle. The needle protector
is an extruded tube. The Sq.
needle hub has a colored
molded insert as a bevel
indicator.	Same
The molded Hub for both
products is functionally
equivalent, as are the
stainless steel needle and
needle protector.	None
The Havel's Hub Assembly has
a metal Bushing and is Glued;
the Spectra Sq. Hub Assembly
is over molded and the Round
Luer Hub Assembly is glued.
The Havel's Hub has a molded
bevel indicator; the Spectra
hub has a printed bevel
indicator. The Havel's needle
has depth marks on the
needle and the Spectra
needles 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"	Same
Similar Gauge Range	None
Spectra 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 Steel
Round Hub = Polypropylene
Square Hub = K-Resin
Protector = LDPE / Polypropylene (Molded)
Lubrication = Silicone	Cannula = 304 Stainless Steel
Square Hub = N/A (PP)
Protector = N/A	Equivalent Materials of Construction	None
Performance	Hub/Cannula Tensile Strength
Penetration Force
Luer Taper	Hub/Cannula Tensile Strength
Luer Taper
Separation 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 others
Device does not contain a thermal source	Same	None

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| 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
Penetration Force | 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
requirements. | Assumed; Biocompatibility
Testing has been conducted
and included with 510(K)
Submission to FDA. | 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 |