(386 days)
No
The 510(k) summary describes a standard mechanical lumbar puncture needle and does not mention any AI or ML components or functionalities.
No
A therapeutic device is used to treat a disease or condition. This device is a lumbar puncture needle used for diagnostic procedures, injecting/withdrawing fluids, and myelography/discography, not for treating a condition.
Yes
The intended use explicitly mentions "withdrawl of fluids for purpose of diagnostic lumbar puncture," indicating its role in obtaining samples for diagnosis.
No
The device description clearly outlines physical components (introducer, stylet, needle, hubs, cannula) made of materials like plastic and stainless steel, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to gain entry into the spinal cavity for injecting or withdrawing fluids for diagnostic lumbar puncture, myelography, and discography procedures. While fluids are withdrawn for diagnostic purposes, the device itself is a tool for accessing the body, not for performing a diagnostic test on a sample in vitro (outside the body).
- Device Description: The device is a needle, introducer, and stylet. These are instruments used to access the body, not reagents, instruments, or systems intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test a sample in vitro. The focus is on the physical act of accessing the spinal cavity and withdrawing fluids.
Therefore, this device falls under the category of a medical device used for accessing the body and collecting samples, but it is not an IVD.
N/A
Intended Use / 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.
Product codes
BSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal cavity
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
licensed clinician
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)
- Product Sterility
- Bacteriostasis and Fungistasis
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOWI
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other ispect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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,
4
Class II, Product Code BSP, Panel: Anesthesiology, cleared 09/22/1993;
Device Comparison Table:
| | IMD's Lumbar
Puncture Needle –
K170112 | Pujunk Lumbar
Puncture Needle –
K160294 | IMD's Fenestrated
Nerve Block
Needle – K113662 | IMD's, Anesthetic
Needles: Touhy,
Quincke, Pencil
Point – K070354 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use: | Single patient use
lumbar puncture
needle used gain
entry into or
puncture the spinal
cavity permitting
injecting (including
anesthesia) /
withdrawal of fluids
for purposed of
diagnostic lumbar
puncture,
myelography
discography
procedures. It is to
be used only under
the direction of a
licensed clinician. | Single patient use
lumbar puncture
needle used gain
entry into or
puncture the spinal
cavity permitting
injecting (including
anesthesia) /
withdrawal of fluids
for purposed of
diagnostic lumbar
puncture,
myelography
discography
procedures. It is to
be used only under
the direction of a
licensed clinician. | Single patient use
peripheral nerve
block needle used to
provide local or
regional nerve
blocking by the
injecting of a local
anesthesia. It is to
be used only under
the direction of a
licensed clinician. | Single patient use
needles intended for
the transient delivery
of anesthetics to
provide regional
anesthesia ...
placement of an
epidural catheter...
used only under the
direction of a
licensed clinician. |
| Length: | 3.5 in. (90 mm)
- 5.0 in (150 mm) | Various (90 – 150
mm) | 3.5 in. (90 mm) and
5.0 in. (150 mm) | Various (22 ga. = 3.5
in. / 90 mm) |
| Gauge: | Various (18 - 27 ga.) | Various (18 - 20 ga.) | 20 ga. | Various (18, 22, 25
ga.) |
| Tip
Configuration: | 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); or
Cyrolite acrylic | Polycarbonate | K-Resin (SBC); or
Cyrolite acrylic | K-Resin (SBC); or
Cyrolite acrylic |
| Stylet | Stainless steel | Stainless steel | Stainless steel | Stainless steel |
| Methods of
Manufacture: | Identical to the
reference IMD
Needles; using
same needle
manufacturer | Similar to IMD | Identical to the IMD
Needles; using
same needle
manufacturer | Identical to the IMD
Needles; using
same needle
manufacturer |
| Cannula: | One (side)
fenestration | One fenestration | Multiple side
fenestrations | 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; using
same contract | Header bag /
pouches. | Same header bag /
pouches; using
same contract | Same header bag /
pouches; using
same contract |
COMPARATIVE (SE) INFORMATION MATRIX
5
| | packaging company
(IPM) with same
validated sealers | packaging company
(IPM) with same
validated sealers | packaging company
(IPM) with same
validated sealers |
|----------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Product
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
UT: EO steriliz'n,
cycle 870 | Unknown | Sterigenics, SLC
UT: EO steriliz'n,
cycle 870 |
| | Nelson Labs, SLC
UT: BI testing | Unknown | Nelson Labs, SLC
UT: BI testing |
| | Nelson Labs: EO
validation (ISO
11135) | Unknown | Nelson Labs: EO
validation (ISO
11135) |
| | Sterigenics, SLC
UT: EO sterilization,
cycle 870 | Nelson Labs, SLC
UT: BI testing | Nelson Labs: EO
validation (ISO
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
6
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 |
| Labs PSC 110, STP0077 Rev 07, USP General | |
| Chapter 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 BFS |
| 120, USP , EP 2.6.1 and ; | |
| 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.