(315 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and sterilization of a standard spinal needle, with no mention of AI or ML capabilities.
Yes
The device is described as being used for "injection of local anesthetics ... to provide spinal anesthesia for pain management," which directly addresses a medical condition (pain) and aims to treat it.
No.
The device is intended for the injection of local anesthetics for pain management, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical needle with various hardware components (stylet, hub, luer connector) and mentions non-clinical tests related to physical properties and biocompatibility, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the Spinal Needle is used for "injection of local anesthetics into the subarachnoid space". This is a procedure performed within the body (in vivo) for therapeutic purposes (pain management).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens with this device.
The device is a surgical/procedural instrument used for delivering medication directly into a specific anatomical site.
N/A
Intended Use / Indications for Use
Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.
Product codes
BSP
Device Description
Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length.
The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues.
Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic.
The needle hub is luer connector (6% luer taper).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare environment
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 7864:2016 4th edition: Sterile hypodermic needles for single use - Requirements and test methods
- o ISO 9626:2016 2nd edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 594-1:1986 1st edition: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- ISO 594-2:1998 2nd edition: Conical fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment - Part 2: Lock fittings
- ISO 80369-7:2016 1st edition: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 6009:2016 4th edition: Hypodermic needles for single use - Colour coding for identification.
Biocompatibility tests were performed in accordance with the following standards:
- . ISO 10993-1:2018 5th edition: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 10993-4:2017 3rd edition: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 3rd edition: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2021 4th edition: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- . ISO 10993-23:2021:15 edition: Biological evaluation of medical devices – Part 23: Tests for irritation
- . ISO 10993-11:2017 3rd edition: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
The device is sterilized by Ethylene oxide sterilization method, the sterilization process was validated as per ISO 11135:2014/AMD 1:2018 2nd edition: Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
The EO residual were tested which meets the requirements of ISO 10993-7:2008 2nd edition: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
The Bacterial endotoxin testing of subject devices was performed by "Gel-Clot Method" and meets the requirement of USP.
Packaging validation and transport study tests were conducted in accordance with the following standard:
- . ISO 11607-1:2019 2nd edition: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2: 2019 2nd edition: Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
- . ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is placed inside a blue square. The text is stacked in three lines, with "ADMINISTRATION" on the bottom line.
July 29, 2022
Global Medikit Limited % Atonu Dutta CEO Alceon 201-203 Tilak Complex, Jetalpur Road Vadodara, Gujarat 390007 India
Re: K212982
Trade/Device Name: Medispine - Spinal Needle, Glospine - Spinal Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: June 30, 2022 Received: July 5, 2022
Dear Atonu Dutta:
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.
1
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 and Part 809); 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 medical devices and radiation-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/cdrh-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.
for 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) K212982
Device Name
Medispine - Spinal Needle and Glospine - Spinal Needle
Indications for Use (Describe)
Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.
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) |
|---|---|
| ☑ | ☐ |
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
1. Submission Sponsor
Global Medikit Limited, Khasra no. 323 (MI), Camp Road, Selaqui, Dehradun, Uttarakhand- 248197, India. Contact Person: Mr. Karun Narang Phone: +91 11 27667889 Email: regulatory@globalmedikit.in
2. Submission Correspondent
Alceon 201-203 Tilak Complex, Jetalpur Road, Vadodara, Gujarat-390 007, India. Contact Person: Mr. Atonu Dutta Phone: (+91) 9925023428 Email: regulatory@alceon.in
3. Date Summary Prepared:
9th September 2021
Device name & classification: 4.
Trade/Proprietary Name: Medispine – Spinal Needle and Glospine – Spinal Needle Common/Usual Name: Anesthesia conduction needle Device classification Regulation: 21CFR Part 868.5150 Product Code: BSP Device Class: Class 2 Classification Panel: Anesthesiology
5. Predicate Device
Trade/Proprietary Name: Spinal Anesthesia Needles Manufacturer: Zhejiang kindly medical devices Co., Ltd Common/Usual Name: Anesthesia conduction needle 510(K): K171518 Device classification Regulation: 21CFR Part 868.5150 Product Code: BSP Device Class: Class 2
Global Medikit Limited
4
Classification Panel: Anesthesiology
6. Device Description
Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length.
The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues.
Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic.
The needle hub is luer connector (6% luer taper).
7. Indications for Use
Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.
8. Comparison to predicate device
The following table compares the subject device to the predicate device with respect to their indications for use, technology and performance testing, thus demonstrating the basis for determination of substantial equivalence between these devices.
| Description | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Trade/Device Name | Spinal Needle | Spinal Anesthesia | |
| Needles | - | ||
| Manufacturer | Global Medikit Limited | Zhejiang kindly medical | |
| devices Co., Ltd | - | ||
| 510 (K) | Applied | K171518 | - |
| Class | Class 2 | Class 2 | - |
| Regulatory number | 21 CFR Part 868.5150 | 21 CFR Part 868.5150 | - |
| Product code | BSP | BSP | - |
| Clinical | |||
| Intended Use | Spinal Needle (Quincke | ||
| Bevel and Pencil Point) | The Spinal Anesthesia | ||
| Needles are | Same | ||
| Description | Subject Device | Predicate Device | Comparison |
| is intended for injection | |||
| of local anesthetics into | |||
| the subarachnoid space | |||
| to provide spinal | |||
| anesthesia for pain | |||
| management. | intended to be used for | ||
| injection of | |||
| local anesthetic agent | |||
| into the | |||
| subarachnoid cavity for | |||
| pain | |||
| management. | |||
| Technical specification | |||
| Stylet Hub | |||
| Stylet | |||
| Needle Tube | |||
| Needle Hub | |||
| Needle Hub Insert | |||
| Protective Cap of | |||
| Needle | Stylet Hub | ||
| Stylet | |||
| Needle Tube | |||
| Needle Hub | |||
| Needle Hub Insert | |||
| Protective Cap of | |||
| Needle | |||
| Product | |||
| Configuration | Same | ||
| Needle gauge | 18G-27G | 18G-27G | Same |
| Needle length | 70 mm, 90 mm, 120 | ||
| mm | 40mm, 50mm, 65mm, | ||
| 70mm, 80mm, | |||
| 90mm, 120mm | Same | ||
| Needle tip | |||
| configuration | Quincke bevel and | ||
| Pencil point | Quincke and Pencile | Same | |
| Sterility | EO sterilized | EO Sterilized | Same |
| Single use | Single use | Single Use | Same |
| Shelf life | 5 years | 3 years | Similar# |
| Label/Labeling | Conform with 21 CFR | ||
| 801 | Conform with 21 CFR | ||
| 801 | Same | ||
| Product | |||
| Performance | Complies with: | ||
| ISO 9626:2016, | |||
| ISO 7864:2016, | |||
| ISO 594-1:1986, | |||
| ISO 594-2:1998 | |||
| ISO 80369-7:2016 | |||
| ISO 6009:2016 | Complies with: | ||
| ISO 9626:1991 AMD | |||
| 1:2001, | |||
| ISO 7864:1993, | |||
| ISO 594-1:1986, | |||
| ISO 594-2:1998 | Same | ||
| Biological | |||
| Needle Material | Stainless steel | Stainless steel | Same |
| Description | Subject Device | Predicate Device | Comparison |
| Biocompatibility | Conform with ISO | ||
| 10993 | Conform with ISO | ||
| 10993 | Same |
5
6
The shelf life of subject device is verified through the stability studies conducted for the device and hence, there are no additional risk generated due to the difference observed in the shelf life of the proposed device compared to the predicate device.
Hence, the device is considered as substantially equivalent to the predicate device.
9. Summary of non-clinical testing
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 7864:2016 4th edition: Sterile hypodermic needles for single use - Requirements and test methods
- o ISO 9626:2016 2nd edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 594-1:1986 1st edition: Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- ISO 594-2:1998 2nd edition: Conical fittings with a 6% (Luer) taper for syringes, needles ● and certain other medical equipment - Part 2: Lock fittings
- ISO 80369-7:2016 1st edition: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 6009:2016 4th edition: Hypodermic needles for single use - Colour coding for identification.
The biocompatibility tests were performed in accordance with the following standards:
- . ISO 10993-1:2018 5th edition: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 10993-4:2017 3rd edition: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 3rd edition: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2021 4th edition: Biological evaluation of medical devices - Part 10: Tests for skin sensitization
7
- . ISO 10993-23:2021:15 edition: Biological evaluation of medical devices – Part 23: Tests for irritation
- . ISO 10993-11:2017 3rd edition: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
The device is sterilized by Ethylene oxide sterilization method, the sterilization process was validated as per ISO 11135:2014/AMD 1:2018 2nd edition: Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
The EO residual were tested which meets the requirements of ISO 10993-7:2008 2nd edition: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
The Bacterial endotoxin testing of subject devices was performed by "Gel-Clot Method" and meets the requirement of USP.
Packaging validation and transport study tests were conducted in accordance with the following standard:
- . ISO 11607-1:2019 2nd edition: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2: 2019 2nd edition: Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
- . ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems
10. Summary of Clinical Testing
No clinical data was included in this premarket application submission.
11. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.