(101 days)
Not Found
No
The summary describes a resorbable pin system and an ultrasonic insertion device. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies focus on mechanical strength, not algorithmic performance.
Yes
The device is used to repair fractures of the craniofacial skeleton and for reconstructive procedures, which are therapeutic interventions.
No
The provided text explicitly states the device's purpose is for "fractures of the craniofacial skeleton" and "reconstructive procedures," which are therapeutic applications, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states it consists of physical pins and an ultrasonic unit (Sonotrode device) for implantation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The RESORB-X® SF is a system of resorbable pins and an ultrasonic device used for the surgical fixation of fractures and reconstructive procedures in the craniofacial skeleton. It is an implanted device used directly on the patient's bone during surgery.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is mechanical fixation within the body.
Therefore, the RESORB-X® SF falls under the category of a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device.
The RESORB-X® SF is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
The RESORB-X® SF Sonotrode is NOT intended for any other use and is only intended for use for insertion of the RESORB-X® SF pins.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The RESORB-X® SF consists of RESORB-X® Pins made of Poly (D, L) - Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with the previously cleared RESORB-X® Resorbable Plating System plates (K011590).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, naso-ethomoidal, infraorbital areas, frontal sinus wall, midface
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)
Mechanical tests have been preformed to compare the strength of the RESORB-X® SF pins with the RESORB-X® screws and the data is included in section F-3. To summarize the findings, the RESORB-X® SF pins have more favorable results (higher strength) than the previously cleared RESORB-X® screws.
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
X051236 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
:
510(K) SUMMARY
AUG 2 2 2005
| AUG 22 2005 | |
|---|---|
| Submitter: | KLS-Martin, L.P. |
| 11239-1 St. Johns Industrial Parkway South | |
| Jacksonville, FL 32246 | |
| Phone: 904-641-7746 | |
| Fax: 904-641-7378 | |
| Contact Person: | Jennifer Damato |
| Director RA/QA | |
| Date of Summary: | 10 May 2005 |
| Device Name: | RESORB-X® SF |
| Trade Name: | RESORB-X® SF |
| Common Name: | Bone Plate |
| Classification | |
| Name and Number: | Bone Plate (872.4760) |
| Regulatory Class: | II |
| Predicate Devices: | RESORB-X® Resorbable Plating System (K011590) |
| Siroson L and Sirosonic Ultrasonic Scalers (K033640) | |
| EMS Piezon® Master 600 (K022328) | |
| Intended Use: | The RESORB-X® SF is intended for fractures of the |
| craniofacial skeleton including, but not limited to, | |
| comminuted fractures of the naso-ethomoidal and | |
| infraorbital areas, comminuted fractures of the frontal | |
| sinus wall, and midface fractures; and reconstructive | |
| procedures of the midface or craniofacial skeleton. | |
| The RESORB-X® SF pins are designed only to | |
| be inserted with the RESORB-X® SF Sonotrode | |
| device. | |
| The RESORB-X® SF is NOT intended for use in the | |
| mandible or full load-bearing situations, nor in areas | |
| of active infection or for patients with conditions | |
| including blood supply limitations, insufficient quantity | |
| or quality of bone, or latent infections. | |
| The RESORB-X® SF Sonotrode is NOT intended for | |
| any other use and is only intended for use for | |
| insertion of the RESORB-X® SF pins. | |
| C-1 |
1
Device Description:
The RESORB-X® SF consists of RESORB-X® Pins made of Poly (D, L) - Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with the previously cleared RESORB-X® Resorbable Plating System plates (K011590).
Technological Characteristics:
Similarities to Predicate
The RESORB-X® SF is identical to RESORB-X® Resorbable Plating System (K011590) in intended use and in chemical composition.
The RESORB-X® SF pin diameters and pin lengths are identical in diameter and length to RESORB-X® Resorbable Plating System (K011590)
The RESORB-X® SF ultrasound unit is similar to the Siroson L and Sirosonic Ultrasonic Scalers (K033640) and the EMS Piezon® Master 600 (K022328) in operating voltages, energy delivered and tip operating frequency.
Differences to Predicate
The RESORB-X® SF pins utilize a dual diameter stepped drill with a stop and does not require the hole to be pre-tapped. The RESORB-X® Resorbable Plating System (K011590) utilizes a single diameter drill and requires the hole to be tapped.
The RESORB-X® SF ultrasound unit produces an ultrasonic force to generate a phase transition in the pin which allows the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The Siroson L and Sirosonic Ultrasonic Scalers (K033640) and the EMS Piezon® Master 600 (K022328) generate an ultrasonic force for dental procedures.
2
The RESORB-X® SF is substantially equivalent in intended use to the RESORB-X® Resorbable Plating System (K011590).
Discussion:
The RESORB-X® SF and the RESORB-X® Resorbable Plating System (K011590) screws are intended for identical surgical procedures. Further, the RESORB-X® SF is used in combination with the exact same RESORB-X® Resorbable Plating System (K011590) plates for fixation.
Mechanical tests have been preformed to compare the strength of the RESORB-X® SF pins with the RESORB-X® screws and the data is included in section F-3. To summarize the findings, the RESORB-X® SF pins have more favorable results (higher strength) than the previously cleared RESORB-X® screws.
The major difference between this product and the previously cleared product is in the method of insertion. Instead of using a drill, tap, screw method of insertion, the RESORB-X® SF uses the characteristics inherent in polymers allowing the polymer to mold into the surrounding space when heated. The heat, in this case, is generated by the fiction between the pin and the surrounding pilot hole though the use of an ultrasonic generator. The "phase" change that allows the pin to mold to the surgical site is temporary and is reversed when the ultrasonic force is removed. The heat that is transferred to the surrounding bone is not significant and is shown in section F-3.
Finally, the frictional heat that is necessary to allow the RESORB-X® SF pins to mold into the pilot hole is well below the temperatures used in manufacturing the product and the previously cleared the RESORB-X® Resorbable Plating System (K011590) screws. The limited duration and low temperature exposure used during insertion does not affect the molecular weight, the resorption or the strength retention of the product as shown in section F-3 and does not adversely affect the product.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Ms. Jennifer Damato Director RA/QA KLS-Martin, L.P. 11239 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K051236
Trade/Device Name: RESORB-X® SF Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: July 22, 2005 Received: July 28, 2005
Dear Ms. Damato:
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.
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.
4
Page 2 - Ms. Damato
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthen V. in for
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K051236 510(k) Number (if known):
Device Name: RESORB-X® SF
Indications For Use:
The RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device.
The RESORB-X® SF is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
The RESORB-X® SF Sonotrode is NOT intended for any other use and is only intended for use for insertion of the RESORB-X® SF pins.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
Page 1 of 1
Division Sign (Uivision Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
B-1