(89 days)
For percutaneous introduction, manipulation, and removal of epidural stimulation leads.
The provided text is a 510(k) submission for a medical device called the "MedAmicus Epidural Introducer." It describes the device, its intended use, and its substantial equivalence to predicate devices, leading to FDA clearance.
Crucially, this document does not include information about acceptance criteria, detailed studies proving device performance, sample sizes for test sets or training sets, ground truth establishment, or expert involvement as described in your request.
The submission focuses on demonstrating substantial equivalence to already cleared predicate devices based on intended use, materials, labeling, method of operation, and manufacturing methods. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for the new device.
Therefore, I cannot provide the requested information from the given text. The text explicitly states:
"MedAmicus believes the MedAmicus Epidural Introducer is safe and effective based on substantial equivalence to the predicate MedAmicus and ANS Introducer Sheaths. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent."
This indicates that the "proof" for meeting acceptance criteria is the argument of substantial equivalence, not a new clinical or performance study with detailed metrics, sample sizes, or expert panels.
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CONFIDENTIAL
Medamicus Inc.
510 (k) Submission
Epidural Introducer
MAR - 1 2000
510(k) Summary
K 994097
MedAmicus Epidural Introducer
Date of Preparation: October 29, 1999
General Information
| Trade Name | MedAmicus Epidural Introducer |
|---|---|
| Classification Name | Introducer, Percutaneous §870.1340 |
| Common Name | Percutaneous Introducer |
| Submitter | MedAmicus, Inc.15301 Highway 55 WestMinneapolis, MN 55447 |
| Contact | Dennis S. MadisonVice President, QualityAssurance/Regulatory Affairs612-559-2613, Fax: 612-559-7548 |
Predicate Devices
Coaxial Dilator from MedAmicus, Inc. (K990705) Introde INT-8 from ANS (Neuromed), Inc. (K930242) ·
Device Description Information
Intended Use
The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705. The intended use of these introducers is for percutaneous introduction, manipulation, and removal of epidural stimulation leads.
Conclusion
MedAmicus believes the MedAmicus Epidural Introducer is safe and effective based on substantial equivalence to the predicate MedAmicus and ANS Introducer Sheaths. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2000
Mr. Dennis S. Madison Vice President, Quality Assurance and Regulatory Affairs MedAmicus. Inc. 15301 Highway 55 West Minneapolis, Minnesota 55447
K994097 Re:
Trade Name: MedAmicus Epidural Introducer Regulatory Class: II Product Code: GZB Dated: November 29, 1999 Received: December 3, 1999
Dear Mr. Madison:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 – Mr. Dennis S. Madison
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Theodore Sayre
So- James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Medamicus Inc.
510 (k) Submission
Epidural Introducer
Statement of Indications for Use
K 994097
For percutaneous introduction, manipulation, and removal of epidural stimulation leads.
Contraindications
None
Russell Page
(Division Sign-Off) Division of General Restorative Devices 510(k) Number -16954097
Prescription Use
(Per 21 CFR 801.109)
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).