Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Device Description

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

AI/ML Overview

The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device:	The device is substantially equivalent to predefined predicate devices (Subdural Evacuating Port System Kit, Ventriculostomy Kits, Cranial Access Kit) in terms of intended use, materials, biocompatibility, design, performance, function, and operating characteristics, and does not raise new safety or effectiveness issues. This was based on successful performance testing and clinical data presented and accepted for the predicate device (K002970).
No New Safety/Effectiveness Issues:	The device was found to introduce no new issues relating to the safety or effectiveness of its intended use compared to the predicate devices.

Acceptance Criteria

Reported Device Performance

Substantial Equivalence to Predicate Device:

The device is substantially equivalent to predefined predicate devices (Subdural Evacuating Port System Kit, Ventriculostomy Kits, Cranial Access Kit) in terms of intended use, materials, biocompatibility, design, performance, function, and operating characteristics, and does not raise new safety or effectiveness issues. This was based on successful performance testing and clinical data presented and accepted for the predicate device (K002970).

No New Safety/Effectiveness Issues:

The device was found to introduce no new issues relating to the safety or effectiveness of its intended use compared to the predicate devices.

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

Sample Size for Test Set: Not explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.

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

MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable.

Summary of Performance Testing (as per document):

The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."

This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.

Summary

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K042359 1/3

NOV 1 7 2004

510(k) Summary

1. Submitter Information:

Medical Designs, LLC NORTH CENTER, Suite 104 1210 W. 18th Street Sioux Falls, South Dakota 57104 (605) 376-6008 (605) 335-3734 Fax e-mail: paxt(a)medicaldesignsllc.com

Contact: Mr. Paul John Axt Preparation Date: August 27, 2004

1. Trade Name:
  Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit)

Common Name: Subdural Fluid Drainage Kit

Classification Name:

Central Nervous System Fluid Shunts and Components Regulation Number: 21 CFR 882.5550 Product Code: JXG

Classification:

The Subdural Evacuating Port System Cranial Access Kit is a Class II device. The Subdural Evacuating Port System Cranial Access kit includes Class II devices covered under Regulations: 21 CFR 882.5550, 21 CFR 882.4300, 21 CFR 880.5860, 21 CFR 880.5570, 21 CFR 878.5020, 21 CFR 878.4370, and Class I devices covered under Regulations: 21 CFR 880.5240, 21 CFR 878.4800, 21 CFR 878.4680, and 21 CFR 878.4014.

3. Predicate Devices:

1. Subdural Evacuating Port System Kit, Medical Designs, LLC, Catalog # 11-9901 (# K002970).
1. Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46156, (#K915546).
1. Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46154, (#K915546).
1. Cranial Access Kit, Integra NeuroSciences, Catalog # INS-HITH .

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Performance Standards: 4.

No applicable performance standards have been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act for this device.

KC42359

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5. Device Description:

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
1. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
1. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

6. Intended Use:

"Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma."

"The Subdural Evacuating Port System Cranial Access kit is contraindicated for patients with acute subdural hematomas, patients undergoing anticoagulant therapy, and is not designed, sold, or intended for use except as indicated."

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7. Biocompatibility:

The surgical instruments and accessories included in the Subdural Evacuating Port System Cranial Access Kit have been approved by the United States Food and Drug Administration, or are substantially equivalent to instruments and accessories approved by the United States Food and Drug Administration for use in neurosurgical procedures.

K042359

(Predicate Device # 1: Subdural Evacuating Port System Kit, Medical Designs, LLC, Catalog # 11-9901 (K002970); Predicate Device # 2: Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46156 (K915546); Predicate Device # 3: Ventriculostomy Kit, Medtronic Neurosurgery, Catalog # 46154 (K915546), and; Predicate Device # 4: Cranial Access Kit, Integra NeuroSciences, Catalog # INS-HITH (510(k) # unknown)

8. Summary of Substantial Equivalence:

The Subdural Evacuating Port System Cranial Access Kit is substantially equivalent in part or in whole to one or more of the predicate devices in terms of intended use, materials, biocompatibility, design, performance, function and operating characteristics, and does not raise any new issues relating to the safety or effectiveness of its intended use.

9. Performance Testing:

The Subdural Evacuating Port System Cranial Access Kit is substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 featuring three abstract human figures in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2004

Mr. Paul John Axt Vice President of Operations Medical Designs, LLC North Center, Suite 104 1210 W. 18" Street Sioux Falls, South Dakota 57104

K042359 Re:

Subdural Evacuating Port System Cranial Access Kit (SEPS) Cranial Access Kit) Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: October 11, 2004 Received: October 13, 2004

Dear Mr. Axt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed above and have determined the device is substantially equivalent to legally marketed reletened doloro and have and interstate commerce prior to May 28, 1976, the enactment date of produce de nevel mannents. You may, therefore, market the device, subject to the general motions provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls ountriols pro fisterib of the requirements for annual registration, listing of devices, good provisions ing practice, and labeling, and prohibitions against misbranding and adulteration.

In addition, we have determined that your product contains the following component(s) subject to regulation as drugs:

ChloraPrep One Step 10.5ml Applicator, .
Povidone-Iodine Ointment (1.5gm), .
Lidocaine w/Epinephrine (30ml). .

Our substantially equivalent determination does not apply to the drug component(s) of your product. For information on applicable Agency requirements for marketing this product, we suggest you contact:

Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

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Page 2 - Mr. Paul John Axt

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 (21 CFR Part 807); 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 (Section 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 although we recommend that you first contact the Center for Drug Evaluation and Research before marketing your drug component[s]. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K042359 510(k) Number (if known):

Subdural Evacuating Port System Cranial Access Kit Device Name:

Indications For Use:

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)

Muriam C. Provost

Division of General, Restorative. and Neurological Devices

Page 1 of

510(k) Number_ K642359

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).