IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures.

The device is intended for adult and pediatric patients.

It is to be used only under the direction of a licensed clinician.

Device Description

The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.

It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called IMD's Lumbar Puncture Needle. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets them from scratch.

Therefore, the information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

The document primarily relies on the equivalency of its design, materials, manufacturing processes, and sterilization methods to previously cleared devices. The "performance" mentioned refers to the device's functional integrity as a medical instrument, rather than clinical efficacy measured through a traditional study.

Here's an attempt to answer your questions based on the available information, noting where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific clinical acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/diagnostic device studies. Instead, it relies on demonstrating that the device is manufactured to established standards and is functionally equivalent to already-cleared devices.

The "performance" referred to here relates to product integrity and manufacturing quality, not clinical outcome or diagnostic accuracy.

Acceptance Criteria (Implied / Functional)	Reported Device Performance (Implied / Functional)
Functional Equivalence: Device shares identical configuration, features, materials, and methods of manufacture/sterilization with reference devices.	The document explicitly states: "IMD's Lumbar Puncture shares the identical configuration, features, materials, methods of manufacture / manufacturer, testing, packaging / packager, and sterilization / sterilizer as the reference needles (IMD's)." It also notes similarity to the predicate device in materials and manufacturing. This forms the core argument for substantial equivalence.
Biocompatibility: Device materials are biocompatible.	"Yes, per ISO 10993" for all devices in the comparison table, indicating compliance with recognized standards for biocompatibility. Biocompatibility testing has been provided in reference device submissions.
Sterility: Device is sterile.	"100% EtO" sterilization process is used, with validation through Nelson Labs (ISO 11135). Tests referenced include "Product Sterility" (USP General Chapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1, JP and 21 CFR 610.12) and "Bacteriostasis and Fungistasis" (USP <71>, EP 2.6.1 and JP XV, and AAMI/ISO 11737-2).
Non-pyrogenic: Device is non-pyrogenic.	Stated as "Non-pyrogenic" for the device and reference devices.
Manufacturing Quality: Production lots are subject to inspection/testing.	"Production Lots are also subjected to inspection / testing by Incoming QC, in-process QC, and finished goods QC, and monitored in the field by means of our CAPA system." This indicates adherence to a Quality Management System (21 CFR Part 820).
Safety and Effectiveness (as predicate): Device is as safe and effective as the predicate when used as intended.	The conclusion states: "It is designed and manufactured to be as safe and as effective as the predicate device when used as intended, under a licensed clinician's supervision." This is an assertion based on the substantial equivalence argument, not on a new clinical study demonstrating safety and effectiveness. "No record of unexpected patient problems or adverse reactions were found in our review of the FDA's MAUDE, Safety Alert, and MDR databases" supports the safety profile of similar devices.

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

Not applicable. This is not a study involving a "test set" in the context of diagnostic performance evaluation (e.g., AI algorithms). The document does not describe a clinical study with a patient test set for the device's performance. The "testing" mentioned refers to manufacturing quality control (e.g., sterility, biocompatibility).

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

Not applicable. No "ground truth" establishment in a diagnostic sense is described. The assessment is mechanical and material equivalency.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described.

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 physical medical instrument (lumbar puncture needle), not an AI algorithm or an imaging device requiring human reader interpretation, hence an MRMC study is irrelevant for this product.

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

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

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

Not applicable. Ground truth for diagnostic accuracy is not relevant here. The ground truth for the "performance" described relates to adherence to manufacturing specifications, material composition, and proven sterilization effectiveness, which are established by standardized laboratory tests and regulatory compliance (e.g., ISO 10993 for biocompatibility, USP/AAMI/ISO standards for sterility).

8. The sample size for the training set

Not applicable. This isn't an AI device requiring a training set.

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

Not applicable. This isn't an AI device requiring a training set.

Summary

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February 2, 2018

International Medical Development, Inc. % John Lincoln Principal Consultant J.E. Lincoln and Associates P.O. Box 2786 St. George, Utah 84771

Re: K170112

Trade/Device Name: IMD's Lumbar Puncture Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 26, 2017 Received: January 2, 2018

Dear John Lincoln:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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

Form Approved: OMB | lo. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement be ow.

510(k) Number (if known)

K170112

Device Name IMD's Lumbar Puncture Needle

Indications for Use (Describe)

The device is intended for adult and pediatric patients.

It is to be used only under the direction of a licensed clinician.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Su part C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

SUBMITTED BY: IMD INC. 560 Hwy 39 PO Box 510 Huntsville UT 84317 (800)-824-8223, or (801) 745-4700

01. DEVICE NAME (Trade/common, and classification):

Common Name: Anesthesia Conduction Needle

Trade Name: IMD's Lumbar Puncture Needle

Product Code: BSP

Regulation Nos .: 868.5150

02. PREDICATE AND REFERENCE DEVICES:

2.1 Predicate Device:
Pajunct's Lumber Puncture Needle, K160294, Regulation Number 868.5150, Class II, Product Code BSP, Panel: Anesthesiology, cleared 10/21/2016; Same Intended Use, materials and method of manufacture are similar; see matrix below;

2.2 Reference Devices:

This submission is identical to the following reference devices in materials, method of assembly / testing, and packaging / sterilization; but one with the addition of side fenestrations (K113662), and all with different Indications for Use:

IMD's Fenestrated Nerve Block Needle (Closed-end Tip / Pencil Point), K113662 Regulation Number 868.5140, Class II, Product Code CAZ, Panel: Anesthesiology, cleared 04/20/2012;

IMD's Anesthesia Needles (Touhy, Quincke, and Pencil Point), K070354 Regulation Number 868.5150, Class II, Product Code BSP, Panel: Anesthesiology, cleared10/05/2007; and

IMD's Anesthetic Needle (Gertie Marx), K931644, Regulation Number 868.5150,

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Class II, Product Code BSP, Panel: Anesthesiology, cleared 09/22/1993;

Device Comparison Table:

	IMD's LumbarPuncture Needle –K170112	Pujunk LumbarPuncture Needle –K160294	IMD's FenestratedNerve BlockNeedle – K113662	IMD's, AnestheticNeedles: Touhy,Quincke, PencilPoint – K070354
IntendedUse:	Single patient uselumbar punctureneedle used gainentry into orpuncture the spinalcavity permittinginjecting (includinganesthesia) /withdrawal of fluidsfor purposed ofdiagnostic lumbarpuncture,myelographydiscographyprocedures. It is tobe used only underthe direction of alicensed clinician.	Single patient uselumbar punctureneedle used gainentry into orpuncture the spinalcavity permittinginjecting (includinganesthesia) /withdrawal of fluidsfor purposed ofdiagnostic lumbarpuncture,myelographydiscographyprocedures. It is tobe used only underthe direction of alicensed clinician.	Single patient useperipheral nerveblock needle used toprovide local orregional nerveblocking by theinjecting of a localanesthesia. It is tobe used only underthe direction of alicensed clinician.	Single patient useneedles intended forthe transient deliveryof anesthetics toprovide regionalanesthesia ...placement of anepidural catheter...used only under thedirection of alicensed clinician.
Length:	3.5 in. (90 mm)- 5.0 in (150 mm)	Various (90 – 150mm)	3.5 in. (90 mm) and5.0 in. (150 mm)	Various (22 ga. = 3.5in. / 90 mm)
Gauge:	Various (18 - 27 ga.)	Various (18 - 20 ga.)	20 ga.	Various (18, 22, 25ga.)
TipConfiguration:	Pencil Point	Sprotte and Quincke	Pencil Point	Pencil Point, et al
Materials:
Needle /Cannula	304 Stainless steel	304 Stainless steel	304 Stainless steel	304 Stainless steel
Hub	K-Resin (SBC); orCyrolite acrylic	Polycarbonate	K-Resin (SBC); orCyrolite acrylic	K-Resin (SBC); orCyrolite acrylic
Stylet	Stainless steel	Stainless steel	Stainless steel	Stainless steel
Methods ofManufacture:	Identical to thereference IMDNeedles; usingsame needlemanufacturer	Similar to IMD	Identical to the IMDNeedles; usingsame needlemanufacturer	Identical to the IMDNeedles; usingsame needlemanufacturer
Cannula:	One (side)fenestration	One fenestration	Multiple sidefenestrations	One fenestration
Biocompat-ibility:	Yes, per ISO 10993	Yes, per ISO 10993	Yes, per ISO 10993	Yes, per ISO 10993
Packaging:	Same header bag /pouches; usingsame contract	Header bag /pouches.	Same header bag /pouches; usingsame contract	Same header bag /pouches; usingsame contract

COMPARATIVE (SE) INFORMATION MATRIX

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	packaging company(IPM) with samevalidated sealers	packaging company(IPM) with samevalidated sealers	packaging company(IPM) with samevalidated sealers
ProductLabeling:	Single- and 10-unit	Single- and multiple	Single- and 10-unit
Sterilization:	100% EtO	100% EtO	100% EtO
	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
	Sterigenics, SLCUT: EO steriliz'n,cycle 870	Unknown	Sterigenics, SLCUT: EO steriliz'n,cycle 870
	Nelson Labs, SLCUT: BI testing	Unknown	Nelson Labs, SLCUT: BI testing
	Nelson Labs: EOvalidation (ISO11135)	Unknown	Nelson Labs: EOvalidation (ISO11135)
	Sterigenics, SLCUT: EO sterilization,cycle 870	Nelson Labs, SLCUT: BI testing	Nelson Labs: EOvalidation (ISO11135)

Note: Only the needle / cannula comes into contact with the patient in routine use.

03. DESCRIPTION:

The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices.

It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.

04. INDICATIONS FOR USE / INTENDED USE:

The device is intended for adult and pediatric patients.

It is to be used only under the direction of a licensed clinician.

05. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE:

The IMD's Lumbar Puncture shares the identical configuration, features, materials, methods of manufacture / manufacturer, testing, packaging / packager, and sterilization / sterilizer as the reference needles (IMD's). Biocompatibility and Performance testing has been provided in the reference device submissions, which support substantial equivalence (SE).

It's Indications for Use is similar to the predicate device and the intended use is the same. The indications differ in minor semantics and include the prescription device statement. Therefore, the different semantics and prescription statement included in the IFU does not change the intended use, and does not affect the safety and effectiveness of the device when used as labeled

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It it is therefore substantially equivalent to the predicate device listed above.

In addition:

No record of unexpected patient problems or adverse reactions were found in our O review of the FDA's MAUDE, Safety Alert, and MDR databases;

Test:	References:
Product Sterility	Cleanroom, Direct transfer method, NelsonLabs PSC 110, STP0077 Rev 07, USP GeneralChapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1,JP and 21 CFR 610.12
Bacteriostasis and Fungistasis	Method II: Direct Inoculation, Nelson Labs BFS120, USP <71>, EP 2.6.1 and <jp 54="" xv,="">;and AAMI/ISO 11737-2.

The device and its packaging was tested by an independent lab for the following: O
Production Lots are also subjected to inspection / testing by Incoming QC, in-process OC, and finished goods QC, and monitored in the field by means of our CAPA system.

06. CONCLUSION:

There are no substantive differences between the device defined in this 510(k) submission and the predicate and reference devices. It is identical or similar in configuration, material and manufacturing / sterilization technologies that are currently used in other similar medical devices. It was developed and documented under IMD's Quality Management System, under the Quality System Regulation, 21 CFR Part 820, including design / change control, and is verified / validated to applicable standards / guidance documents, including vendors' and our SOPs. It is designed and manufactured to be as safe and as effective as the predicate device when used as intended, under a licensed clinician's supervision. IMD's Lumbar Puncture Needle share similar or identical Indications for Use,and characteristics, materials,

manufacturer, sterilization, and functional features, and thus are substantially equivalent to the currently marketed predicate and reference devices, cited above.

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).