(211 days)
Not Found
No
The summary describes a mechanical needle with a safety shield and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is described as an anesthesia conduction needle used to deliver an anesthetic and/or therapeutic agent; it is a delivery mechanism, not a therapeutic agent itself.
No
Explanation: The device is described as an "anesthesia conduction needle" used for "delivering an anesthetic and/or therapeutic agent" and "injection of local anesthetics." Its purpose is to administer substances, not to diagnose conditions.
No
The device description clearly states it is an anesthesia conduction needle with a physical tip shielding mechanism, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver anesthetic and/or therapeutic agents for regional anesthesia. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a needle for injecting substances into body cavities. This is a tool for administering treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely for delivering a substance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Functional and simulated clinical testing was performed to support that there are no new issues or effectiveness raised by adding the sharps injury protection feature. The SPpro™ ESP met all functional requirements and specifications. Clinical simulation testing was in accordance with the Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features: Guidance for Industry and FDA issued on December 31, 2002.
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
APR 2 2 2004
Image /page/0/Picture/2 description: The image contains the text "InVaMed" in a large, bold font at the top left of the image. Below this text, there is another line of text that reads "These are wondrous". The background of the image is black, and the text is white, creating a high contrast. There is also a small, blurry image in the center of the image.
Tim Duvall President Office Number (925) 820-3128
InVaMed Technologies, Inc. 9955 Titan Park Circle / Littleton, CO 80125 Corp. Phone 303-346-5300 Fax 303-346-9120
510(k) Summary - Dated September 19, 2003
General Information
| Classification: | Class II |
|---|---|
| Trade Name: | SPpro™ - ESP |
| Submitter: | InVaMed Technologies, Inc. |
| 9955 Titan Park Circle | |
| Littleton, CO 80125 | |
| Contact: | Tim Duvall |
| President | |
| (925) 820-3128 |
1
Device Identification
-
A. Common Name
Epidural Needle with Sharps Injury Protection Feature Spinal Needle with Sharps Injury Protection Feature -
B. Classification Name
Needle, Conduction, Anesthetic (W/WO Introducer)
C. Regulation Number
858.5150
D. Panel
Anesthesiology
E. Product Code
BSP
- F. Class
Class II
Predicate Devices
Manan Epidural Needle from Manan Medical Products, Inc. K980536 Manan Spinal Needles from Manan Medical Products, Inc. K983620 Perifix Safety Epidural Needle from B. Braun Medical, Inc. K013610
Device Description Information
Intended Use
The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
2
Device Description
The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.
Biocompatibility
Although the SPpro™ ESP sharps injury protection device has no direct contact with internal body fluids the materials and assembly methods were selected to provide for transient external tissue contact biocompatibility.
Biocompatibility testing on the therapeutic portion of the device included all tests performed on the predicate devices. The therapeutic devices are already approved devices made for InVaMed Technologies by Manan Medical Products, Inc.
Device Performance/Product Testing
Functional and simulated clinical testing was performed to support that there are no new issues or effectiveness raised by adding the sharps injury protection feature. The SPpro™ ESP met all functional requirements and specifications. Clinical simulation testing was in accordance with the Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features: Guidance for Industry and FDA issued on December 31, 2002.
3
Technology Characteristics
The therapeutic device is equivalent technologically to the devices mentioned under predicate devices above. The therapeutic devices are already approved devices made for InVaMed Technologies by Manan Medical Products, Inc.
The safety feature, which has been integrated with the therapeutic portion of the device, is the reason for this submission. The safety feature is an active shielding system that that incorporates a second hub section integrated with the luer portion of the needle that slides up from the needle hub and locks over the needle tip. A second feature incorporates a plastic sheath attached to the sliding portion and the luer hub, which covers the previously exposed canula of the needle.
Substantial Equivalence
The InVaMed SPpro ESP needle incorporates an active needle tip cover mechanism to minimize needle stick injuries when used to access non-vascular areas of the body to administer local anesthetics. The basic design, methods of manufacturing, and materials used in the therapeutic portion of the device are substantially equivalent to the predicate devices, Manan Epidural Needle and Manan Spinal Needles from Manan Medical Products, Inc. While basic design, methods of manufacturing, and materials used in the safety portion of the device differ the technological equivalence exist between the predicate devices, Perifix® Safety Epidural Needle from B. Braun Medical, Inc. Our application for this device is substantially equivalent to the aforementioned devices already approved for use. The clinical indications for use remain unchanged. InVaMed believes the SPpro ESP anesthesia conduction needle is substantially equivalent to currently marketed anesthesia conduction needles and an anesthesia conduction needle with sharps injury protection features.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2004
Mr. Tim Duvall President InVaMed Technologies; Incorporated 9955 Titan Park Circle Littleton, Colorado 80125
Re: K032981
Trade/Device Name: SPpro ESP, Modcls ESP 603-18-05 and ESP 603-18-09 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: March 16, 2004 Received: March 19, 2004
Dear Mr. Duvall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Mr. Tim Duvall
You must comply with all the Act's requirements, including, but not limited to: registration r ou indist configry with a 807); labeling (21 CFR Part 801); good manufacturing practice and home (2) as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct radiation control provisions (Sections 531-542 of the Act); appreadio, and other will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence in your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n 900 donto the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj over it Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Ravis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: SPpro ESP
Indications For Use:
The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.W. Westerhem
esthesiology, General Hospital,
Page 1 of i
510(k) Number. K032981
Section 1 - 9