(227 days)
Not Found
No
The device description and intended use describe a simple stainless steel wire and sleeve for mechanical fixation. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a surgical wire used for fixation, which is a structural or mechanical function, rather than directly treating or preventing a disease or condition in a therapeutic manner.
No
The device description and intended use indicate that the Sprytie™ wire is used for fixation and wiring of bony segments, teeth, arch bars, or splints. This is a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a physical wire made of stainless steel, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the body (in the jaws) for mechanical fixation and stabilization of bony segments and teeth. This is a surgical/mechanical function, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical wire and sleeve designed for surgical placement and manipulation within the jaw. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sprytie™ wire does not fit this description.
N/A
Intended Use / Indications for Use
Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).
Product codes (comma separated list FDA assigned to the subject device)
DZK
Device Description
The Sprytie™ is a 25, 26, or 27 gauge annealed 316L stainless steel wire 7 inches in length, with a hollow 22TW, 23TW, or 24TW sieeve crimped over one end of the wire, respectively.
The Sprytie™ is used in place of traditional light gauge stainless steel surgical wire during the placement of arch bars and splints, direct intraosseous wiring, bridal wire placement, and direct maxillomandibular fixation (ivy loops, risden wires, etc.). The sleeve end is inserted around the teeth first. The stiffness of the sleeve prevents the flexure of the wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaws
Indicated Patient Age Range
adults and children
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): 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.
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
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
5-1
1082
510(k) Summary
807.92(c)
Sponsor
APR - 2 2010
807.92(a)(1)
Submitter Russell Walther 6026 Martel Avenue Dallas, Texas 75206
Contact Person: Russell Walther Telephone: 817-992-0232 Fax: 817-249-0771
Date Prepared: August 10, 2009
Device Name
807.92(a){2)
| Proprietary Name: | Sprytie™ (models ST001, ST002, ST003) |
|---|---|
| Common/Usual Name: | Stainless Steel Wire for Maxillary and |
| Mandibular Fixation | |
| Classification: | Class II |
| Dental Classification Panel | |
| Wire, Fixation, Intraosseous | |
| Regulation Number: | 872.4880 |
| Product Code: | DZK |
Predicate Devices
807.92(a)(3)
| Predicate Device #1: | Aragon Wiring System, K022821 |
|---|---|
| Predicate Device #2: | Erich Arch Bar, K061271 |
Device Description
807.92(a){4)
The Sprytie™ is a 25, 26, or 27 gauge annealed 316L stainless steel wire 7 inches in length, with a hollow 22TW, 23TW, or 24TW sieeve crimped over one end of the wire, respectively.
1
A.K092530
The Sprytie™ is used in place of traditional light gauge stainless steel surgical wire during the placement of arch bars and splints, direct intraosseous wiring, bridal wire placement, and direct maxillomandibular fixation (ivy loops, risden wires, etc.). The sleeve end is inserted around the teeth first. The stiffness of the sleeve prevents the flexure of the wire.
Device Intended Use
Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).
Device Technological Characteristics
The wire component of the Sprytie™ is identical to predicate devices. The Sprytie™ includes a ¾ inch 304 stainless steel sleeve crimped over one end. In predicate devices the wire is packaged in 75-675 ft length reusable spools. The predicate devices do not contain the 304 stainless steel portion.
Conclusion
The Sprytie™ has the same intended use as predicate devices, as well as substantially equivalent technical specifications. The modification to a traditional 316L stainless steel wire with the addition of a 304 stainless steel sleeve improves the ease of use of the wire, and does not change the intended use of the wire. The Sprytie™ is as safe, as effective, and performs as well as or better than predicate devices.
807.92(b)(3)
807.92(a)(6)
807.92(a)(5)
5-2
2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 2 2010
Mr. Russell B. Walther Russell B. Walther 6026 Martel Avenue Dallas, Texas 75206
Re: K092530
Trade/Device Name: Sprytie™M Regulation Number: 21CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZK Dated: March 18, 2010 Received: March 24, 2010
Dear Mr. Walther:
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 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.
3
Page 2- Mr. Walther
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.goy/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hn for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4-1
Indications for Use
510(k) Number (if known):
Device Name: Sprytie™
Indications for Use:
Sprytie™ wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together (maxillomandibular fixation).
Prescription Use _X (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 IF NEEDED)
rrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Orvision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: