(58 days)
Orthologic Orthonail
Not Found
No
The description focuses solely on the mechanical design and intended use of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for stabilizing humeral fractures, which is a therapeutic intervention.
No
The device is used for stabilizing humeral fractures, which is a therapeutic rather than a diagnostic function. It's a physical implant, not a tool for identifying medical conditions.
No
The device description clearly describes a physical implant (a nail with specific geometry, threads, and screw holes) used for stabilizing fractures, which is a hardware medical device.
No, the Perry Nail device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Perry Nail Function: The description clearly states the Perry Nail is a device for stabilizing humeral fractures. This is a surgical implant used directly on the bone within the body. It does not analyze biological samples.
The information provided about the device's geometry, screw types, and intended use all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Perry Nail device is indicated for stabilizing humeral fractures.
Product codes
HSB
Device Description
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. A summary of the nail configurations to be offered is displayed in Table 1.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orthologic Orthonail
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
4/1/99
ડ.
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
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. A summary of the nail configurations to be offered is displayed in Table 1.
| 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.
2
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
4
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)