The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.

AI/ML Overview

This document, K013120, is a 510(k) summary for a Percutaneous Introducer Set. The device is intended for the introduction, manipulation, and removal of stimulation leads.

The document indicates that the device's substantial equivalence is based on its similarity to a predicate device, the MedAmicus Epidural Introducer (K994097), in terms of intended use, basic design, manufacturing methods, and materials.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document
does NOT list specific acceptance criteria with quantifiable metrics, nor does it provide a detailed table of reported device performance against such criteria.

Instead, it offers a general statement: "Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device."

To infer potential "acceptance criteria" based on the provided information, we can consider the aspects of similarity to the predicate device and relevant material properties:

Acceptance Criterion (Inferred from document)	Reported Device Performance (as stated in document)
Intended Use Equivalence: Percutaneous introduction, manipulation, and removal of stimulation leads.	"The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads." "The intended use... are similar to the predicate device..."
Basic Design Equivalence: Physical structure and components (sheath, dilator, guidewire).	"The basic design... are similar to the predicate device..." Detailed description of components: HDPE sheath, HDPE hub, 304 stainless steel dilator, 304 SS guidewire, platinum iridium marker band.
Manufacturing Methods Equivalence: Processes used to produce the device.	"The methods of manufacturing... are similar to the predicate device..." "The sheath materials and manufacturing processes for the Percutaneous Introducer Set are equivalent to those used on the predicate MedAmicus device..."
Material Equivalence: Composition of parts that come into contact with the patient or leads.	"The materials are similar to the predicate device..." "Materials used in the Percutaneous Introducer Set are identical to materials previously approved/cleared for market release." (Specific examples: HDPE identical to K990705, 304 SS identical to P970004, Platinum Iridium identical to P970004).
Biocompatibility: Safety for contact with tissue.	"Applications referred to below are for Externally Communicating - Blood Path Indirect - Limited Exposure which includes all the testing required above." "Since the materials are identical to those previously approved/cleared, there are no new issues involving safety and effectiveness."
Sterility: Assurance of being free from viable microorganisms.	"Present sterilization cycle assures a Sterility Assurance Level (SAL) of >10-6."
Packaging Equivalence: Maintenance of sterility and physical integrity.	"The packaging materials for the Percutaneous Introducer Set are equivalent to the predicate MedAmicus Epidural Introducer. These materials consist of a double sterile barrier using Tyvek/Mylar pouches."

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on a specific "test set" with a defined sample size or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on establishing substantial equivalence to a predicate device, and the "performance data" mentioned is a general statement, not a detailed study report.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The submission focuses on device equivalence rather than a study requiring expert-established ground truth for a test set.

4. Adjudication Method

This information is not provided in the document. As no specific test set or expert ground truth establishment is described, neither is an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. The document aims for substantial equivalence based on physical and functional characteristics, not on the impact of the device on human readers' performance with or without AI assistance.

6. Standalone Performance Study

A standalone (algorithm-only without human-in-the-loop performance) study was not performed or reported in this 510(k) submission. This is a medical device, not an AI/algorithm-based diagnostic tool. The "performance data" mentioned is a general statement about meeting functional requirements.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in the context of diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) does not apply directly to this 510(k) submission. The "truth" for this submission is based on the demonstration of substantial equivalence to a legally marketed predicate device and the "identicality" of materials to those previously approved.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As there is no training set for an AI/machine learning model, there is no ground truth establishment for such a set.

Summary

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JAN 2 4 2002

510(k) Summary Dated 1/15/02

General Information

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Classification:	Class II
Trade Name:	Percutaneous Introducer Set
Submitter:	MedAmicus, Inc.15301 Highway 55 WestMinneapolis, MN 55447
Contact:	Karyl HaskellQuality and Regulatory Affairs Mana

Quality and Regulatory Affairs Manager
763-577-2257

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013120

Device Identification

Device Proprietary Name A.
Percutaneous Introducer Set
B. Device Common name
Percutaneous Introducer
C. Device Classification name and reference
Therapeutic Devices, Neurological Reference 882.5880

Sec. 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).
D. Device proposed regulatory class

Class II

Device product code E.
GZB
F. Classification Panel
Neurological
Device Performance Standards G.
To date no special controls have been established for these devices. Performance standards as required by Section 514 of the Federal Food, Drug and Cosmetic act and implemented by 21CFR Part 861 have not been established for percutaneous introducer sets.

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Predicate Device

MedAmicus Epidural Introducer (K994097)

Device Descriptive Information

General Description

Intended Use

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads

Biocompatability

Per ISO 10993 this device is classified as Externally Communicating -Tissue/Bone/Dentin Communicating - Limited Exposure. Applications referred to below are for Externally Communicating - Blood Path Indirect - Limited Exposure which includes all the testing required above.

Materials used in the Percutaneous Introducer Set are identical to materials previously approved/cleared for market release. The materials of the sheath, sheath hub, and dilator hub are identical to those used in the MedAmicus Coaxial Introducer (K990705) which is a predicate device for the Epidural Introducer. Both the Epidural and Coaxial Introducer use HDPE with the exception that the Epidural Introducer uses a blue dye in the sheath shaft. The 304 stainless steel use in the dilator shaft and directional guide is identical to the cannulas of Medtronic foramen needles (P970004). The platinum iridium used as a marker band in the introducer sheath is identical to the electrodes of Medtronic stimulation leads (P970004). Since the materials are identical to those previously approved/cleared, there are no new issues involving safety and effectiveness.

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KOI3120.
Page 4 of 5

Device Performance/Product Testing

Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device.

Technology Characteristics

The device is equivalent technologically to the device mentioned under predicate device above.

Substantial Equivalence

Substantial Equivalence Discussion

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads. The intended use, basic design, methods of manufacturing, and materials are similar to the predicate device, the MedAmicus Epidural Introducer.

The sheath materials and manufacturing processes for the Percutaneous Introducer Set are equivalent to those used on the predicate MedAmicus device, the MedAmicus Epidural Introducer (K994097). The 304 stainless steel use in the dilator shaft and guidewire has been used in numerous applications and in particular by Medtronic (P970004) in the cannulas of their foramen needles. The platinum iridium has also been used in numerous applications and in particular by Medtronic (P970004) in the electrodes of their leads.

The packaging materials for the Percutaneous Introducer Set are equivalent to the predicate MedAmicus Epidural Introducer. These materials consist of a double sterile barrier using Tyvek/Mylar pouches. Present sterilization cycle assures a Sterility Assurance Level (SAL) of >10-6.

Substantial Equivalence Conclusion

The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads. The basic design, methods of manufacturing, and materials used are substantially equivalent to the predicate device, MedAmicus Epidural Introducer (K994097). The application of this device is substantially equivalent to the aforementioned device already cleared for market release. The clinical indications for use remain unchanged. MedAmicus

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believes the Percutaneous Introducer Set is substantially equivalent to currently marketed medical introducers employing the same technology and is therefore safe and effective.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Ms. Karyl Haskell Quality Assurance & Regulatory Affairs Manager Medamicus, Inc. 15301 Highway 55 West MINNEAPOLIS, MN 55447

Re: K013120 Trade/Device Name: Model 042294 Lead Introducer Set and Model 3550-18 Lead Introducer Kit Regulation Number: 21 CFR §882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: II Product Code: 84 GZB Dated: December 14, 2001 Received: December 17, 2001

Dear Ms. Haskell:

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 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. 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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Applicant: _ MedAmicus, Inc. Applican: Internet (if known): New Submission LL13120 510(K) Number (II Known): Trans 3550-18 Percutaneous Introducer Set Indications For Use:

The Percutaneous Introducer Set is indicated for percutaneous introduction, manipulation, and removal of stimulation leads.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Nancy C. Brandon

(Division Sign Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number _

Prescription Use . 1 … (Per 21 CFR 801.109)

Regulation Number and Section

§ 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).