(183 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and safety/effectiveness of a disposable spinal anesthesia needle, with no mention of AI or ML technology.
Yes
The device is used for pain management, which falls under the scope of therapeutic applications in medicine.
No
The device is intended for the injection of a local anesthetic, which is a therapeutic action for pain management, not for diagnosing a condition.
No
The device description clearly outlines a physical medical device (needles) and the performance studies focus on physical characteristics and biocompatibility, with no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for injecting a local anesthetic agent into the subarachnoid cavity for pain management. This is a therapeutic procedure performed directly on a patient.
- Device Description: The description details a needle designed for physical insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.
Product codes
BSP
Device Description
The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal Anesthesia Needle has a tightly fitting removable stylet that completely occludes the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal Anesthesia Needles are also available with an introducer. Available sizes are 18G to 29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The introducers are available in sizes of 18G-22G with needle lengths of 25-50mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subarachnoid cavity
Indicated Patient Age Range
Not Found
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)
Tests were performed on the UNIEVER Disposable Spinal Anesthesia Needles including verification/validation testing to internal specifications which demonstrated that the device is safe and effective. Testing confirmed that the UNIEVER Disposable Spinal Anesthesia Needles comply with relevant voluntary safety standards, specifically ISO standards 594-1, 7864, and 9626. In addition, evaluations and validations have been performed to demonstrate compliance to the standards biocompatibility (Cytotoxicity, Sensitization, applicable for Irritation/Intracutaneous Reactivity, and Pyrogenicity) and sterilization including additional endotoxin and particulate testing for CSF contact.
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2014
Unisis Corp, Inc. c/o Ms. Diane Rutherford Submission Manager Ken Block Consulting 1201 Richardson Dr., Suite #280 Richardson, TX 75080
Re: K141126
Trade/Device Name: UNIEVER Disposable Spinal Anesthesia Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: October 2, 2014 Received: October 3, 2014
Dear Ms. Rutherford:
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.
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); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number: K141126
Device Name: UNIEVER Disposable Spinal Anesthesia Needle
Indications for Use:
UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.
Prescription Use __ X (21 CFR 801 Subpart D)
AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Page 1 of 1
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5. 510(k) SUMMARY
| Submitter: | UNISIS Corp
2675-1, NISHIKATA
Koshigaya-shi, Saitama 343-0822 Japan |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Unisis Corp
Mr. Tadashi Yasuda
Medical Information Department
2623-1, NISHIKATA
Koshigaya-shi, Saitama 343-0822 Japan
TEL: 048-990-8250
FAX: 048-990-8251
m-info@unisis.co.jp |
| Date Prepared: | April 15, 2014 |
| Trade Name: | UNIEVER Disposable Spinal Anesthesia Needle |
| Common Name: | Spinal Anesthesia Needle |
| Classification Name: | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code: | BSP Class 2 868.5150 |
| Predicate Device: | K112515 B.Braun Pencan Spinal Needles, Spinocan Spinal Needles,
Spinal Introducer Needles
K110194 Medline Medline Epidural and Spinal Needles |
| Device Description: | The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of
sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal
Anesthesia Needle has a tightly fitting removable stylet that completely occludes
the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles
are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal
Anesthesia Needles are also available with an introducer. Available sizes are 18G to
29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The
introducers are available in sizes of 18G-22G with needle lengths of 25-50mm. |
| Statement of
Intended Use: | UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection
of local anesthetic agent into the subarachnoid cavity for pain management. |
| Summary of
Technological
Characteristics: | As with the predicates, the UNIEVER Disposable Spinal Anesthesia Needles are
single use, terminally sterilized devices available in various gauge/length
combinations including the overall ranges of 18G - 29G and 30mm to 150mm. The
proposed device shares technological characteristics with the predicate devices. The
proposed device also has some differences in technological characteristics from
those of the predicate devices. The differences in the technological characteristics
are minor and reflect market strategy and do not impact the safety, effectiveness, or
substantial equivalence of the device. |
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Summary of Technological Characteristics: (Continued)
The UNIEVER Disposable Spinal Anesthesia Needles share the same indications for use with both predicates. One difference exists in that the K112515 predicate includes indications for CSF sample collection while both the UNIEVER and the K110194 predicate do not include this additional indication.
The UNIEVER Disposable Spinal Anesthesia Needles offer both Quincke and Pencil Point needle types as well as an introducer or guide needle [identical to both K112515 and K110194]. The UNIEVER Disposable Spinal Anesthesia Needles and the predicates are manufactured with materials commonly used in medical devices: stainless steel, polycarbonate, and polypropylene. Both the UNIEVER and the K110194 predicate identify the identical biocompatibility category, contact, and duration, and both reference testing for sensitization, irritation, and cytotoxicity. UNIEVER Disposable Spinal Anesthesia Needles as well as both predicates are sterilized using ethylene oxide (EO). UNIEVER Disposable Spinal Anesthesia Needles have a 5 year shelf life [identical to K112515].
Minor differences do exist between the UNIEVER Disposable Spinal Anesthesia Needles and the predicates. For example, the UNIEVER Disposable Spinal Anesthesia Needles offer a 29G needle while the two predicates have 25G [K110194] or 27G [K112515] as the smallest gauge offered. The UNIEVER Disposable Spinal Anesthesia Needles also differ in the minimum and maximum needle lengths offered with the UNIEVER needles ranging from 30mm - 150mm (28mm - 50mm for the introducer) with the predicates offering 25mm - 156mm (35mm for introducer) [K112515] and 90mm (38mm introducer) [K110194]. All the lengths offered for the UNIEVER Disposable Spinal Anesthesia Needles fall within the ranges offered by the identified predicates.
Manufacturers offer different needle gauges and needle lengths based on the marketability of the device. This is common in the marketplace. As all the needles offered are tested for compliance to the same international standards (ISO 7864 and ISO 9626) this difference does not impact the safety, effectiveness, or substantial equivalence of the device.
Tests were performed on the UNIEVER Disposable Spinal Anesthesia Needles Summary of Performance Testing: including verification/validation testing to internal specifications which demonstrated that the device is safe and effective. Testing confirmed that the UNIEVER Disposable Spinal Anesthesia Needles comply with relevant voluntary safety standards, specifically ISO standards 594-1, 7864, and 9626. In addition, evaluations and validations have been performed to demonstrate compliance to the standards biocompatibility (Cytotoxicity, Sensitization, applicable for Irritation/Intracutaneous Reactivity, and Pyrogenicity) and sterilization including additional endotoxin and particulate testing for CSF contact.
- Unisis Corp considers the UNIEVER Disposable Spinal Anesthesia Needle to be Conclusion: substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.