The Perry nail geometry consists of a tubular proximal region and a distal blade region. The tubular proximal region displays a 10° lateral bend and an upper portion of the tube with internal threads created to house one or two bone screw locking cannulated set screws. The device is designed to accept transfixing screws. The two proximally located transfixing screw holes allow ± 15° anterior/posterior inclination of either 6.5mm cancellous or 4.5mm cortical screws into the humeral head and trochanter fragments.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the "Perry Nail," which is an intramedullary fixation rod for stabilizing humeral fractures.

However, the provided text does not contain any information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested.

The document is a summary of the device, its intended use, a comparison to a predicate device (Orthologic Orthonail), and the FDA's clearance letter for market. It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, which is a different regulatory pathway than providing specific performance study results against predefined acceptance criteria for a new, novel device.

Therefore, I cannot populate the table or answer your specific questions with the information provided. The document states "Performance Data" but then immediately follows with "The Perry nail device was predicated on the use of the Orthologic Orthonail," implying that the performance data relied on the predicate device's established performance rather than a new, detailed study for the Perry Nail's specific acceptance criteria.

If you have a different document that contains this information, please provide it.

Summary

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510(K) Summary

990322

Pioneer Surgical Technology 510(K) Notification Summary For Perry Nail

Administrative Information

Manufacturer Identification and Sponsor:

Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 FAX: 906-226-9932

Official Contact:

Burns Severson Vice President, Regulatory Affairs/Quality Assurance

Date Prepared:

Device Identification

Proprietary Name: Perry Nail

Common Name: Humeral Nail

Classification Name and Reference: Intramedullary Fixation Rod Regulation Number: 21 CFR 888.3020, ClassII Classification Number: 87HSB

Devices on which substantial equivalence is claimed:

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Perry Nail 510(K) Summary Establishment Registration Number: 1833824 Page 2

Device Description

Proximal Ø (mm)	Distal Ø (mm)	Blade Configurations		Lengths (mm)
11	8	Slot	No Slot	195 to 270 x 15
11	9	Slot	No Slot	225 to 300 x 15
11	10	Slot	No Slot	240 to 315 x 15
11	11	Slot	No Slot	240 to 315 x 15
12	12	Slot	No Slot	240 to 315 x 15

Table 1: Perry Nail Configurations

The instrumentation includes the following components for inserting/ removing the nail and guiding the designated screws through the nail. The Nail Locking Bolt slips inside the Angle Arm Base engaging the proximal threads of the nail in combination with the tabs and slot engagement between the Angle Arm Base and the nail. A Combination Wrench tightens the head of the Nail Locking Bolt. If some insertion or extraction force is necessary, the impactor slide is passed over the impactor guide followed by the engagement of the guide with the internal threads of the Nail Locking Bolt. The Targeting Guide is positioned on the Angle Arm Bases' locating pins and secured to it by the Targeting Guide Locking Bolt.

Intended Use

The Perry Nail device is indicated for stabilizing humeral fractures.

Technological Characteristic Compared to Predicate Device

Performance Data

The Perry nail device was predicated on the use of the Orthologic Orthonail.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 11 1999

Mr. Burns Severson Senior Vice President Requlatory Affairs/Quality Assurance Pioneer Laboratories 375 River Park Circle Marquette, Michigan 49855-1781

K990322 Re: Perry Humeral Nail Trade Name: Requlatory Class: II Product Code: HSB February 1, 1999 Dated: February 2, 1999 Received:

Dear Mr. Severson:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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Page 2 - Mr. Burns Severson

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 and additionally 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 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,

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

Enclosure

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K990322

Pioneer Surgical Technology

Perry Nail

Indications for Use

The Perry Nail device is indicated for use in stabilizing humeral fractures.

Aseel

(Division)Sign-Off) Division of General Restorative Devices Kgg0322 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.