(207 days)
Not Found
No
The summary describes a mechanical fixation device and its performance testing, with no mention of AI or ML technologies.
No
The device is an implant for fixation in bones, not a device used for therapy. Its purpose is mechanical support and stabilization.
No
The "Arrowhead Fixation Device" is indicated for fixation of osteotomies, arthrodeses, and reconstruction, which are all treatment procedures, not diagnostic ones.
No
The device description clearly states it is an implant manufactured from stainless steel, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of osteotomies, arthrodeses, and reconstruction in the lesser toes. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable fixation device made of stainless steel. This is a physical device used for structural support within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
IVDs are used to perform tests on samples taken from the body to provide information about the body. This device is used within the body to provide structural support.
N/A
Intended Use / Indications for Use
The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The Arrowhead Fixation Device implant features a three dimensional arrow shape. The implants are available in multiple lengths and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes
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)
Substantial equivalence was shown through Rotational Forces Testing, Pull-out Testing and Four-Point Bend Testing. The testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022599, K052736, K072710, K963433, K101165, K100414
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
OCT 2 9 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ARROWHEAD FIXATION DEVICE - K100926
| Submitted by: | Arrowhead Products LLC
2593 Lake Erma Drive
Hampton, GA 30228 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 18, 2010 |
| Contact Person: | Scott R. Roman, DPM
Phone: (404) 583-0248
Fax: (954) 333-2520
Email: romandpm@comcast.net |
| Proprietary Name: | Arrowhead Fixation Device |
| Common Name | Intramedullary Bone Fastener |
| Device
Classification
Regulation | 21 CFR 888.3040 - Class II |
| Device Product
Code and Panel | HTY: Pin, Fixation, Smooth
87 Orthopedics |
| Device Description | The Arrowhead Fixation Device implant features a three dimensional
arrow shape. The implants are available in multiple lengths and in 2
different angles. The implant is manufactured from stainless steel and is
designed for single use only. |
| Intended Use | The Arrowhead is indicated for fixation of osteotomies, arthrodeses and
reconstruction in the lesser toes following corrective procedures. It is not
intended for use in the spine. |
| Predicate Devices | newdeal, S.A. K-wire (K022599)
Arthrex, Inc. K-wire (K052736)
Nexa Orthopedics, Inc. Nexfix Compression Pin (K072710)
BioPro Inc., DCS (K963433)
Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (K101165)
Merete Medical GMBH PRO TOE Endosorb Small Hammer Toe Pin
(K100414) |
| Technological
Characteristics | The Arrowhead Fixation Device has similar technological characteristics
when compared to the predicate devices. In addition, substantial
equivalence was shown through Rotational Forces Testing, Pull-out
Testing and Four-Point Bend Testing. The testing confirmed that the
Arrowhead Fixation Device is at least equivalent to the newdeal K-wire. |
| Substantial
Equivalence
Information | The Arrowhead Fixation Device is similar to legally marketed devices
including the newdeal K-wire, Arthrex K-wire, Nexfix Compression Pin,
BioPro DCS, PRO-TOE VO Hammertoe, and the PRO TOE Endosorb
Small Hammer Toe Pin. The Arrowhead Fixation Device has similar
indications for use and technological characteristics as these predicate
systems. While the Arrowhead Fixation System includes an arrow design
at the ends of the device, mechanical testing confirmed that the device is
substantially equivalent to the newdeal K-wire. Therefore, the Arrowhead
Device System is determined to be substantially equivalent to the
predicate devices. |
1
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ARROWHEAD FIXATION DEVICE - K100926
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings, and three curved lines below representing its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arrow Products. Inc. c/o Dr. Scott Roman Podiatrist 2593 Lake Erma Drive Hampton, Georgia 30228
OCT 2 9 2010
Re: K100926 .
Trade/Device Name: Arrowhead Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HTY Dated: October 26, 2010 Received: October 27, 2010
Dear Dr. Roman:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Dr. Scott Roman
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mulh N Mllkuss
Mark N. Meikerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K100926
Device Name: Arrowhead Fixation Device
Indications for Use:
The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonata for mxm
(Di Sion Sign O Division of Surgical, Offhopedic, and Restorative Devices
510(k) Number K100926
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