IMD's Lumbar Puncture Needle
Device Facts
| Record ID | K170112 |
|---|---|
| Device Name | IMD's Lumbar Puncture Needle |
| Applicant | International Medical Development, Inc.(Imd) |
| Product Code | BSP · Anesthesiology |
| Decision Date | Feb 2, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K170112 · Feb 2, 2018 | IMD's Lumbar Puncture Needle | International Medical Development, Inc.(Imd) | FDA MAUDE database; FDA Safety Alert database; FDA MDR (Medical Device Reporting) database | The sponsor performed a retrospective review of FDA postmarket surveillance databases (MAUDE, Safety Alert, and MDR) to assess the safety profile of similar predicate and reference devices as part of the substantial equivalence justification. | Postmarket surveillance; MAUDE; MDR; Safety profile |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Review of FDA Postmarket Databases; Retrospective database review | Patients reported in FDA postmarket databases for similar lumbar puncture and anesthesia needles; Number of Sites: Not applicable | Not applicable for this study | Incidence of unexpected patient problems or adverse reactions |
Indications for Use
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 Story
Single-patient-use lumbar puncture needle; used to access spinal cavity for fluid withdrawal or injection of substances (e.g., anesthesia) during diagnostic procedures like myelography or discography. Device consists of introducer, stylet, and pencil-point needle with plastic hub and stainless steel cannula. Operated by licensed clinician in clinical setting. Provides physical access to spinal space; output is the successful puncture and subsequent fluid exchange or injection. Benefits include facilitating diagnostic and therapeutic spinal procedures.
Clinical Evidence
Bench testing only. Device sterility validated per ISO 11135 and ISO 11737-2. Biocompatibility confirmed per ISO 10993. No clinical data presented.
Technological Characteristics
Needle/cannula: 304 stainless steel. Hub: K-Resin (SBC) or Cyrolite acrylic. Stylet: stainless steel. Gauges: 18-27G. Lengths: 3.5-5.0 inches. Tip: Pencil point. Sterilization: 100% EtO. Biocompatibility: ISO 10993 compliant.
Indications for Use
Indicated for adult and pediatric patients requiring entry into or puncture of the spinal cavity for diagnostic lumbar puncture, myelography, or discography procedures, or for the injection of substances (including anesthesia) and withdrawal of fluids. To be used only by a licensed clinician.
Regulatory Classification
Identification
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Predicate Devices
- Pajunct's Lumber Puncture Needle (K160294)
Reference Devices
- IMD's Fenestrated Nerve Block Needle (K113662)
- IMD's Anesthesia Needles (Touhy, Quincke, and Pencil Point) (K070354)
- IMD's Anesthetic Needle (Gertie Marx) (K931644)
Submission Summary (Full Text)
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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)
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.
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)
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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 Lumbar<br>Puncture Needle –<br>K170112 | Pujunk Lumbar<br>Puncture Needle –<br>K160294 | IMD's Fenestrated<br>Nerve Block<br>Needle – K113662 | IMD's, Anesthetic<br>Needles: Touhy,<br>Quincke, Pencil<br>Point – K070354 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use: | Single patient use<br>lumbar puncture<br>needle used gain<br>entry into or<br>puncture the spinal<br>cavity permitting<br>injecting (including<br>anesthesia) /<br>withdrawal of fluids<br>for purposed of<br>diagnostic lumbar<br>puncture,<br>myelography<br>discography<br>procedures. It is to<br>be used only under<br>the direction of a<br>licensed clinician. | Single patient use<br>lumbar puncture<br>needle used gain<br>entry into or<br>puncture the spinal<br>cavity permitting<br>injecting (including<br>anesthesia) /<br>withdrawal of fluids<br>for purposed of<br>diagnostic lumbar<br>puncture,<br>myelography<br>discography<br>procedures. It is to<br>be used only under<br>the direction of a<br>licensed clinician. | Single patient use<br>peripheral nerve<br>block needle used to<br>provide local or<br>regional nerve<br>blocking by the<br>injecting of a local<br>anesthesia. It is to<br>be used only under<br>the direction of a<br>licensed clinician. | Single patient use<br>needles intended for<br>the transient delivery<br>of anesthetics to<br>provide regional<br>anesthesia ...<br>placement of an<br>epidural catheter...<br>used only under the<br>direction of a<br>licensed clinician. |
| Length: | 3.5 in. (90 mm)<br>- 5.0 in (150 mm) | Various (90 – 150<br>mm) | 3.5 in. (90 mm) and<br>5.0 in. (150 mm) | Various (22 ga. = 3.5<br>in. / 90 mm) |
| Gauge: | Various (18 - 27 ga.) | Various (18 - 20 ga.) | 20 ga. | Various (18, 22, 25<br>ga.) |
| Tip<br>Configuration: | Pencil Point | Sprotte and Quincke | Pencil Point | Pencil Point, et al |
| Materials: | | | | |
| Needle /<br>Cannula | 304 Stainless steel | 304 Stainless steel | 304 Stainless steel | 304 Stainless steel |
| Hub | K-Resin (SBC); or<br>Cyrolite acrylic | Polycarbonate | K-Resin (SBC); or<br>Cyrolite acrylic | K-Resin (SBC); or<br>Cyrolite acrylic |
| Stylet | Stainless steel | Stainless steel | Stainless steel | Stainless steel |
| Methods of<br>Manufacture: | Identical to the<br>reference IMD<br>Needles; using<br>same needle<br>manufacturer | Similar to IMD | Identical to the IMD<br>Needles; using<br>same needle<br>manufacturer | Identical to the IMD<br>Needles; using<br>same needle<br>manufacturer |
| Cannula: | One (side)<br>fenestration | One fenestration | Multiple side<br>fenestrations | One fenestration |
| Biocompat-<br>ibility: | Yes, per ISO 10993 | Yes, per ISO 10993 | Yes, per ISO 10993 | Yes, per ISO 10993 |
| Packaging: | Same header bag /<br>pouches; using<br>same contract | Header bag /<br>pouches. | Same header bag /<br>pouches; using<br>same contract | Same header bag /<br>pouches; using<br>same contract |
# COMPARATIVE (SE) INFORMATION MATRIX
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| | packaging company<br>(IPM) with same<br>validated sealers | packaging company<br>(IPM) with same<br>validated sealers | packaging company<br>(IPM) with same<br>validated sealers |
|----------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Product<br>Labeling: | 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, SLC<br>UT: EO steriliz'n,<br>cycle 870 | Unknown | Sterigenics, SLC<br>UT: EO steriliz'n,<br>cycle 870 |
| | Nelson Labs, SLC<br>UT: BI testing | Unknown | Nelson Labs, SLC<br>UT: BI testing |
| | Nelson Labs: EO<br>validation (ISO<br>11135) | Unknown | Nelson Labs: EO<br>validation (ISO<br>11135) |
| | Sterigenics, SLC<br>UT: EO sterilization,<br>cycle 870 | Nelson Labs, SLC<br>UT: BI testing | Nelson Labs: EO<br>validation (ISO<br>11135) |
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:
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.
# 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, Nelson<br>Labs PSC 110, STP0077 Rev 07, USP General<br>Chapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1,<br>JP and 21 CFR 610.12 |
| Bacteriostasis and Fungistasis | Method II: Direct Inoculation, Nelson Labs BFS<br>120, USP <71>, EP 2.6.1 and <jp 54="" xv,="">;<br/>and AAMI/ISO 11737-2.</jp> |
- 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.
