The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901. The Hand Drill is not intended for any use other than that indicated.

Device Description

The hand drill consists of a black ABS plastic housing, glass filled nylon handle and ABS plastic handle knob. The hand drill has lubricated aluminum gears and a ¼" spring loaded, chrome plated steel, 3-jaw chuck assembly. The hand drill is a single-use disposable device. It is sterilized using gamma radiation.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Hand Drill (Catalog # 11-9901-7) manufactured by Medical Designs, LLC. The primary goal of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a predicate device that is already legally marketed in the U.S. This type of submission generally does not include a formal study with acceptance criteria and device performance as one might find for a PMA (Premarket Approval) or De Novo submission, especially for a Class II manual surgical instrument.

Therefore, the requested information elements related to specific performance acceptance criteria, clinical study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), and training set information are not applicable or present in this 510(k) summary.

Instead, the demonstration of safety and effectiveness relies on comparison to a predicate device and similarities in design, materials, and intended use.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission does not include a formal clinical study with pre-defined acceptance criteria and reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The criteria for acceptance in a 510(k) are based on demonstrating substantial equivalence to a predicate device, primarily through comparison of intended use, technological characteristics, and safety/effectiveness profiles.

2. Sample Sized used for the test set and the data provenance

Not applicable. No formal test set or clinical data is presented for performance evaluation in this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for a test set is not established as no performance study is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth for a performance study is not relevant for this 510(k) submission.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. Ground truth for a training set is not relevant for this 510(k) submission.

Summary of the 510(k) Approach for this Device:

The 510(k) submission for the Medical Designs Hand Drill establishes substantial equivalence to the Integra NeuroSciences Camino Hand Drill - Model 030 (K862160) by demonstrating:

Identical Intended Use: Both devices are intended for use in Neurosurgical procedures. The Medical Designs Hand Drill also specifies use with their Subdural Evacuating Port System Kit (S.E.P.S.), which is a further specific application within neurosurgery.
Similar Technological Characteristics: The submission states that the Medical Designs hand drill is made of "the same materials and components as the predicate device" (ABS plastic housing, glass filled nylon handle, ABS plastic handle knob, lubricated aluminum gears, ¼" spring-loaded, chrome-plated steel, 3-jaw chuck assembly). The device is also a single-use disposable and sterilized using gamma radiation.
Biocompatibility: The materials are stated to be identical to the predicate device, and neither device comes into direct contact with the body or bodily fluids when used as intended. This addresses biocompatibility concerns by similarity.
No new issues of safety or effectiveness: By using identical materials and having the same intended use, the submission argues that the device does not raise any new safety or effectiveness concerns compared to the predicate.

The FDA's review and clearance (NOV 12 2002) indicate their agreement that substantial equivalence was demonstrated, allowing the device to be marketed. This regulatory pathway does not typically require an extensive performance study with quantitative acceptance criteria as would be needed for novel or higher-risk devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Medical Designs LLC. The logo is in black and white and features the words "MEDICAL DESIGNS" in large, bold letters. Above the letter "A" in "MEDICAL" is an image of a surgical instrument. Below the company name is the text "Surgical Instruments Designed by Doctors".

213 Sunset Drive Brandon, SD 57005 Phone: (605)376-6008 Fax: (605)335-1489 E-mail: axt1@worldnet.att.net

NOV 1 2 2002

510(k) Summary

1. Submitter Information:

Medical Designs, LLC 213 Sunset Drive Brandon, South Dakota 57005 (605) 376-6008 (605) 335-1489 Fax e-mail: paxt(@medicaldesignsllc.com

Contact: Mr. Paul John Axt Preparation Date: August 13, 2002

2. Trade Name:

Hand Drill (Catalog # 11-9901-7)

Common Name: Cranial hand drill

Classification Name:

Drills, Burrs, Trephines & Accessories (Manual)

Classification:

The Medical Designs hand drill is a Class II device (21 CFR 882.4300)

1. Predicate Device:
  Integra NeuroSciences Camino Hand Drill - Model 030 (K862160)

4. Performance Standards:

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

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5. Device Description:

The hand drill is a single-use disposable device. It is sterilized using gamma radiation.

6. Intended Use:

The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System (S.E.P.S.) Kit, Catalog # 11-9901.

The Hand Drill is not intended for any use other than that indicated.

7. Biocompatibility:

The materials used to manufacture Medical Designs' hand drill are identical to the materials used to manufacture the predicate device. When used as intended, neither the Medical Designs hand drill nor the predicate device come in direct contact with the body or bodily fluids.

8. Summary of Substantial Equivalence:

The Medical Designs hand drill has the same intended use as the Integra NeuroSciences Camino hand drill. Both are intended for use in Neurosurgery and Neurosurgical procedures.

The Medical Designs hand drill is made of the same materials and components as the predicate device and, therefore, does not raise new issues relating to the safety or effectiveness of its intended use.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 2002

Medical Designs, LLC Paul John Axt Vice President of Operations 213 Sunset Drive Brandon, South Dakota 57005

Re: K022712

Trade/Device Name: Hand Drill, Model 11-9901-7 Regulation Number: 882.4300 Regulation Name: Drills, Burrs, Trephines and Accessories (Manual) Regulatory Class: Class II Product Code: HBG Dated: August 13, 2002 Received: August 14, 2002

Dear Mr. Axt:

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. Iisting 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. 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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Page 2 – Mr. Paul John Axt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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.

Sincerely yours,
muriam C. Provost

for 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

Enclosure

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Statement of Indications for Use

"The Medical Designs Hand Drill is intended for use in Neurosurgical procedures and for use with Medical Designs' Subdural Evacuating Port System Kit (S.E.P.S), Catalog # 11-9901."

"The Hand Drill is not intended for any use other than that indicated."

Miriam C. Provost

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number_k022712

Regulation Number and Section

§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories

(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).