K Number
K992348
Device Name
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
Manufacturer
Date Cleared
1999-09-23

(71 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.
Device Description
Synthes Spiral Blade is used in conjunction with Synthes Solid Humeral Nail. The Synthes SBHN has a self-cutting blade tip, is cannulated, has suture holes located around periphery of blade head, and is available in lengths ranging from 34 mm to 54 mm. A Locking End Cap is used to lock the Spiral Blade in place.
More Information

Not Found

K/DEN number:

No
The summary describes a mechanical implant (spiral blade and nail) for fracture stabilization and does not mention any software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is intended to stabilize fractures of the humerus, which is a therapeutic function.

No
The device, Synthes Spiral Blade for Humeral Nail, is intended for stabilizing fractures of the humerus, which is a therapeutic function rather than a diagnostic one.

No

The device description clearly describes a physical implantable device (Synthes Spiral Blade for Humeral Nail) with specific dimensions and features, not a software-only product.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
  • Device Description and Intended Use: The description clearly states that the Synthes Spiral Blade is used in conjunction with a humeral nail to stabilize fractures of the humerus. This is a surgical implant used within the body to treat a physical condition.

The information provided describes a surgical implant, not a diagnostic test performed on a sample.

N/A

Intended Use / Indications for Use

Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

Product codes

JDS

Device Description

Synthes Spiral Blade is used in conjunction with Synthes Solid Humeral Nail. The Synthes SBHN has a self-cutting blade tip, is cannulated, has suture holes located around periphery of blade head, and is available in lengths ranging from 34 mm to 54 mm. A Locking End Cap is used to lock the Spiral Blade in place.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

humerus

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)

Synthes Unreamed Humeral Nail (a.k.a. Solid Humeral Nail)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small "®" symbol is located to the right of the word, indicating that it is a registered trademark.

K992348

:

| Attachment VI: | Summary of Safety and Effectiveness Information
[510(k) Summary] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
| | Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Spiral Blade for Humeral Nail (SBHN) |
| COMMON OR USUAL
NAME | Intramedullary fixation rod;
Smooth or threaded metallic bone fixation fastener |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 888.3020 and 888.3040 |
| PREDICATE DEVICE: | Synthes Unreamed Humeral Nail (a.k.a. Solid Humeral Nail) |
| DESCRIPTION: | Synthes Spiral Blade is used in conjunction with Synthes
Solid Humeral Nail. The Synthes SBHN has a
self-cutting blade tip, is cannulated, has suture holes located
around periphery of blade head, and is available in lengths
ranging from 34 mm to 54 mm. A Locking End Cap is used to
lock the Spiral Blade in place. |
| INTENDED USE: | Synthes Spiral Blade for Humeral Nail is intended to stabilize
fractures of the humerus. |

Attachment VI:

: :

... .----

: 大

Spiral Blade for Humeral Nail

Synthes (USA)

CONFIDENTIAL

:

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301

Re: K992348

Trade Name: Synthes Spiral Blade for Humeral Nail Regulatory Class: II Product Code: JDS Dated: July 13, 1999 Received: July 14, 1999

Dear Ms. Musgnung:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

2

Page 2 - Ms. Sheri L. Musgnung

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) 594-4595. 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,

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small "R" in a circle is located to the right of the word "SYNTHES", indicating that it is a registered trademark.

Indications for Use Statement 2.0

Page1 of 1
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510(k) Number (if known):
K992348

Synthes Spiral Blade for Humeral Nail Device Name:

Indications For Use:

Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

tcoell

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992348

CONFIDENTIAL