(61 days)
No
The device description and performance studies focus on the mechanical and material properties of a needle and catheter set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an intradiscal injection needle intended to provide access into the intervertebral disc for discography and injection of fluids. It is a tool for diagnostic procedures and fluid delivery, not a direct therapeutic intervention that treats a condition itself.
Yes
The device is described as providing access for "discography," which is a diagnostic procedure used to identify the source of back pain.
No
The device description clearly outlines physical components (needles, catheter, hubs) and mentions bench and functional testing related to these physical attributes, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The DiscCath Needle Set is a surgical instrument used to physically access the intervertebral disc and inject fluids. It is used in vivo (within the living body) for a procedure (discography and injection), not for analyzing a specimen in vitro (outside the living body).
The description clearly outlines a device used for a direct medical procedure on a patient, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids.
The device is intended for adult patients.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The DiscCath Needle Set is a single-use intradiscal injection needle comprised of a 17 gauge x 6" Introducer Needle and a 21 gauge x 10.2 inch (nominal) Injection Catheter. The Introducer Needle is comprised of a stainless-steel cannula and metal hub with a stainless-steel stylet with metal hub. The Introducer Needle has a cannula and stylet match ground bevel point at the distal tip which allows for penetration into the intervertebral disc.
The Injection Catheter is comprised of a nitinol shape-set tube and a molded plastic hub. The injection catheter tubing is flexible with a curved tip welded closed at the distal end and includes a laser cut side-hole that allows for the injection of a fluid.
When used as intended, the Introducer Needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the Introducer Needle stylet, the curved catheter is then inserted through the Introducer Needle cannula and slowly advanced to the target anatomy.
The DiscCath Needle Set is sterilized by ethylene oxide and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intervertebral disc
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Performance testing of the final, sterilized DiscCath Needle Set included bench testing and functional testing to verify specifications fundamental to the device. Testing included the following:
- -Visual Inspection of Components
- -Dimensional Verification of Components
- -Functionality Testing
- -Kink Resistance
- Luer Testing per ISO 80369-7:2016 and ISO 80369-20:2015 -
- -Luminal Patency per ISO 7864:2016
- -Stiffness (Deflection per ISO 9626 Annex B)
- -Component Tensile Strength compared with the predicate Pakter device
- -Introducer Cannula and Injection Catheter Resistance to Breakage
- -Corrosion Resistance per ISO 11070:2014 Annex B
- -Comparative Particulate Testing
- -Radiopacity testing in accordance with ASTM F640-12, and
- -Packaging Integrity & Shelf-Life Validation
Physician simulated use testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device. The DiscCath Needle Set met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
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.
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.
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
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
September 26, 2021
DiscCath LLC Gregory Lutz Chief Executive Officer 62 E 88th Street New York, New York 10128
Re: K212328
Trade/Device Name: DiscCath Needle Set Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: July 23, 2021 Received: July 27, 2021
Dear Gregory Lutz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212328
Device Name DiscCath Needle Set
Indications for Use (Describe)
The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids.
The device is intended for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart 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 BELOW.
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 aspect 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
K212328
Submission Type: Traditional 510(k)
Submitter Information:
DiscCath LLC. 62 E 88th Street New York, NY 10128
Contact Person:
Gregory E. Lutz, M.D. CEO DiscCath LLC. 62 E 88th Street New York, NY 10128 Telephone: 609-356-2449 e-mail: lutzg@regensportscare.com
Date Prepared:
July 19, 2021
Subject Device Information:
| Proprietary Name: | DiscCath Needle Set |
|---|---|
| Common Name: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Classification Name: | Anesthesia Conduction Needle |
| Regulation: | 21 CFR 868.5150 |
| Product Code: | BSP |
| Device Classification: | Class II |
| Classification Panel: | Anesthesiology |
Predicate Devices:
| Proprietary Name: | Pakter Curved Needle Set (Primary) |
|---|---|
| Manufacturer: | Cook Incorporated |
| 510(k) Number: | K173155 |
| Common Name: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Classification Name: | Anesthesia Conduction Needle |
| Regulation: | 21 CFR 868.5150 |
| Product Code: | BSP |
| Device Classification: | Class II |
| Classification Panel: | Anesthesiology |
4
The selected primary predicate is appropriate based on similarity in indications for use, principle of operation as well as materials and other technological characteristics between it and the DiscCath Needle Set. Where differences exist between the subject and predicate device, the differences are bridged using the following reference predicates:
| Reference Devices | ||
|---|---|---|
| Device | IMD Lumbar Puncture Needle | |
| (Reference Predicate) | SPINECATH Intradiscal | |
| Catheter (Reference Predicate) | ||
| Manufacturer | International Medical | |
| Development, Inc. | Oratec Interventions, Inc. | |
| 510(k) | ||
| Reference/Clearance | ||
| Date | K170112 / February 2, 2018 | K993967 / December 17, 1999 |
| Regulation | 21 CFR 868.5150 | 21 CFR 878.4400 |
| Product Code | BSP | GEI |
| Classification | II | II |
| Reason for Reference | Spinal needle with closed-end tip | |
| with side holes indicated for | ||
| discography procedures | Intradiscal catheter provided | |
| with 17 gauge introducer. |
Device Description:
The DiscCath Needle Set is a single-use intradiscal injection needle comprised of a 17 gauge x 6" Introducer Needle and a 21 gauge x 10.2 inch (nominal) Injection Catheter. The Introducer Needle is comprised of a stainless-steel cannula and metal hub with a stainless-steel stylet with metal hub. The Introducer Needle has a cannula and stylet match ground bevel point at the distal tip which allows for penetration into the intervertebral disc.
The Injection Catheter is comprised of a nitinol shape-set tube and a molded plastic hub. The injection catheter tubing is flexible with a curved tip welded closed at the distal end and includes a laser cut side-hole that allows for the injection of a fluid.
When used as intended, the Introducer Needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the Introducer Needle stylet, the curved catheter is then inserted through the Introducer Needle cannula and slowly advanced to the target anatomy.
The DiscCath Needle Set is sterilized by ethylene oxide and intended for single use.
Indications for Use:
5
The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids. The device is intended for adult patients.
Comparison of Technological Characteristics to the Predicate Device:
The DiscCath Needle Set is substantially equivalent in intended use, principles of operation and fundamental technological characteristics to the legally marketed predicate device. The below table summarizes the similarities and differences in design, materials and dimensions between the subject and predicate device.
| Comparison with
Predicate | | SUBJECT DEVICE
DiscCath Needle Set | PREDICATE DEVICE
Pakter Curved Needle Set
(K173155) |
|--------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | | 21 CFR § 868.5150 | 21 CFR § 868.5150 |
| Product Code
Classification | | BSP
II | BSP
II |
| Indications for Use | | The DiscCath and Needle Set
is intended to provide
access into the
intervertebral disc for
discography and injection of
fluids. The device is
intended for adult patients. | The Pakter Curved Needle
Set is intended for
discography, diagnostic
sampling, aspiration, and
injection. |
| Device is for One-time
Use | | Yes | Yes |
| Device Configuration | | Needle and catheter coaxial
set consisting of a 17 gauge
stainless steel outer needle
and stylet and a 21 gauge
flexible curved nitinol
needle. | Two needle coaxial set consisting
of a 21 gauge stainless steel outer
needle and stylet and a 25 gauge
flexible curved nitinol needle and
stylet |
| Curved Needle/Catheter | Catheter
Material | Nitinol | Nitinol |
| | Catheter Hub
Material | Polymer | Polymer |
| | Length | 26 cm | 15, 20 cm |
| | Size | 21 gauge | 25 gauge |
| | Tip
Configuration | Curved, with
welded blunt tip | Curved 30° bevel |
| | Distal
Opening | One (side) fenestration | End opening |
6
| Comparison with
Predicate | | SUBJECT DEVICE
DiscCath Needle Set | PREDICATE DEVICE
Pakter Curved Needle Set
(K173155) |
|------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Introducer Needle/Stylet | Cannula/
Stylet
Material | Stainless Steel | Stainless Steel |
| | Cannula/
Stylet Hub
Material | Metal | Acrylic |
| | Cannula Size | 17 gauge | 21 gauge (0.82mm) |
| | Cannula
Length | 15.24 cm (6 inches) | 10, 15 cm |
| | Needle/Stylet
Tip Point
Configuration | Bevel ground point needle
with an angle of 11° $\pm$ 3° and
matched angled tip stylet | Trocar tip with beveled ground
point stylet |
| Packaging | | Tray in a pouch | Peel Pouch |
| Sterilization Method | | EtO | EtO |
| Sterility Assurance Level | | 10-6 | 10-6 |
| Non-pyrogenic | | Yes | Unknown – Not indicated on
labeling |
The subject and primary predicate device differ from one another primarily with respect to size, length and end-hole configuration. The differences are bridged when considering other commercially available needles/catheters used for intradiscal procedures. Specifically, similar to the DiscCath Injection Catheter, the SPINECATH Intradiscal Catheter (K993967) is provided with a 17 gauge Introducer Needle offered in lengths up to 9 inches (approx. 23 cm). Similar to the DiscCath Injection Catheter, the IMD Lumbar Puncture Needle (K170112) is also offered with a closed end tip with side port fenestration. Although, the 26 cm DiscCath Injection Catheter is longer than the Pakter Curved Needle Set (provided in lengths of 15 and 20 cm); the length of the catheter is comparable to the SPINECATH device (provided in a length up to approx., 23 cms). The length of the DiscCath Injection Catheter has been selected to allow access to the posterior annulus and does not raise new questions of safety or effectiveness.
Performance Data
Performance testing of the final, sterilized DiscCath Needle Set included bench testing and functional testing to verify specifications fundamental to the device. Testing included the following:
- -Visual Inspection of Components
- -Dimensional Verification of Components
- -Functionality Testing
- -Kink Resistance
- Luer Testing per ISO 80369-7:2016 and ISO 80369-20:2015 -
7
- -Luminal Patency per ISO 7864:2016
- -Stiffness (Deflection per ISO 9626 Annex B)
- -Component Tensile Strength compared with the predicate Pakter device
- -Introducer Cannula and Injection Catheter Resistance to Breakage
- -Corrosion Resistance per ISO 11070:2014 Annex B
- -Comparative Particulate Testing
- -Radiopacity testing in accordance with ASTM F640-12, and
- -Packaging Integrity & Shelf-Life Validation
Physician simulated use testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device. The DiscCath Needle Set met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
Biocompatibility Testing
A biocompatibility evaluation was conducted in accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," consistent with an externally communicating device with tissue/bone/dentin for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final, sterilized DiscCath Needle Set:
- Cytotoxicity
- Sensitization
- . Irritation or Intracutaneous Toxicity
- . Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Direct and Indirect Hemolysis
The DiscCath Needle Set does not have direct or indirect contact with cerebrospinal fluid (CSF). A risk assessment was performed to address the potential for neurotoxicity to address this additional biocompatibility endpoint under atypical conditions of use. The catheter is designed with a flexible tip and therefore is unable to penetrate the dura. As the catheter placement and fluid administration procedure is performed under radiologic visualization (fluoroscopy and/or CT) the physician performing the discography would know if the needle/catheter penetrated to the level of the dura and would immediately retract the device. For this reason testing to address neurotoxicity endpoints is not required. In conclusion, the DiscCath Needle Set does not present a risk for contacting CSF and therefore biocompatibility testing presented herein is consistent with FDA/ISO guidance for an externally communicating device with
8
Page 6 of 6
tissue/bone/dentin for a limited duration (≤24 hours) is sufficient for establishing biological safety of the device for its intended use.
Sterility
The DiscCath Needle Set is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 106. The sterilization process was validated per ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. EO residuals were within accepted limits. The bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test, was validated to establish that the DiscCath Needle Set endotoxin level will be