(47 days)
The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Blunt Nerve Block Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study.
Crucially, this document is a 510(k) summary for a "Blunt Nerve Block Needle." Medical devices of this type typically do not have performance acceptance criteria in the same way as AI/software devices. Therefore, many of the requested elements for an AI product's study will not be present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: Similar to predicate Pajunk Sprotte Needles. | The Blunt Nerve Block Needle has similar physical and technical characteristics to the Pajunk Sprotte Needles. |
| Intended Use: For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter. | The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia. (Matches intended use of predicate according to the submission.) |
| Safety and Effectiveness: Demonstrated through substantial equivalence to predicate. | Conclusion: The comparison to the predicate device demonstrates that the Blunt Nerve Block Needle is safe and effective and is substantially equivalent to the predicate device(s). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is for a physical medical device (a needle), not a diagnostic AI or imaging device that would typically have a "test set" of data. The submission relies on a comparison to a predicate device.
- Data Provenance: Not applicable. The "study" isn't a data-driven performance study in the AI sense, but rather a regulatory comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not an AI/software device, so an MRMC study is not relevant or included.
- Effect Size of Human Reader Improvement with AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For this submission, the "ground truth" equivalent is the established safety and effectiveness of the predicate devices (Pajunk Sprotte Needles). The Epimed needle is deemed safe and effective because it is substantially equivalent to these already-approved devices, which are presumed to have established their "truth" through prior regulatory pathways and clinical use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" for this type of medical device submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable.
Summary of the "Study" (or lack thereof, for AI purposes):
The submission for the Epimed International, Inc. Blunt Nerve Block Needle is a 510(k) Premarket Notification based on substantial equivalence to predicate devices. It does not involve a study with acceptance criteria, test sets, or ground truth in the way an AI/software medical device would.
Instead, the "study" is a non-clinical comparison that asserts:
- The device has similar physical and technical characteristics to the Pajunk Sprotte Needles (K911260, K911221, K911202).
- The device has the same intended use as the predicate devices: "For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter."
- No bench testing of performance characteristics was conducted as the submission relies solely on this similarity and intended use to the predicates.
The conclusion is that because it is sufficiently similar to an already legally marketed device with a known safety and effectiveness profile, the new device is also considered safe and effective, and therefore, substantially equivalent.
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AUG 2 4 2004
Section II
510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of QA/RA
Trade Name:
Blunt Nerve Block Needle
Common Name:
Pencil Point Needle
Product Class/Classification:
Class II
Predicate Device(s):
Pajunk Sprotte Needles (K911260, K911221, K911202)
Description:
The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub.
The Blunt Nerve Block Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
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Intended Use:
For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter.
Comparison to Predicate:
The Blunt Nerve Block Needle has similar physical and technical characteristics to the Pajunk Sprotte Needles.
Non-Clinical Data:
Submission is based upon similar physical characteristics and intended use to the predicate devices. No bench testing of performance characteristics was conducted.
Conclusion:
The comparison to the predicate device demonstrates that the Blunt Nerve Block Needle is safe and effective and is substantially equivalent to the predicate device(s).
Epimed International, Inc.
Chasl
Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance
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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2004
Mr. Christopher B. Lake Manager of Regulatory Affairs/ Quality Assurance Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095
Re: K041843
Trade/Device Name: Blunt Nerve Block Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: July 7, 2004 Received: July 13, 2004
Dear Mr. Lake:
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.
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.
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Page 2 - Mr. Lake
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of 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), please contact 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 Division of 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,
Chin Lin, Ph.D.
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
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Indications for Use
510(k) Number (if known): was koy 1843
Device Name: Blunt Nerve Block Needle Indications for Use:
The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cui Suom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number:
KOHK4
§ 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).