(134 days)
Not Found
No
The summary describes a self-setting calcium phosphate cement and its delivery system, with no mention of AI or ML capabilities.
Yes
The device delivers Hydroset XT, a calcium phosphate cement that fills bony voids and augments provisional hardware, which directly contributes to the treatment and healing of skeletal defects.
No
The device is a self-setting calcium phosphate cement used to fill bony voids or gaps; it is a therapeutic/restorative device, not a diagnostic one.
No
The device description explicitly states it includes physical components like syringes, a syringe cap, luer adapter, luer cap, threaded plunger, and cannula, which are hardware.
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 delivery of a bone cement to an orthopedic surgical site to fill bony voids or gaps. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a system for mixing and delivering a calcium phosphate cement. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the cement (working time, setting time) and safety (bacterial endotoxin testing), which are relevant to a surgical implant/filler, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site.
HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, FMF
Device Description
HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre-filled liquid syringe and a pre-filled powder syringe utilized for mixing and delivery of the cement. The device also includes the necessary components to prepare and deliver the cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). After preparation, the cement may be delivered by traditional plunger advancement or by rotating the threaded plunger to deliver the cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, craniofacial, posterolateral spine, and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical site
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)
Performance testing was completed for HydroSet XT to determine its suitability for use. The following tests were performed to evaluate the performance of HydroSetXT: Working Time (Injectability and Torque)
Compression Setting Time (Wet Field Penetration Resistance)
Bacterial endotoxin testing (BET) as specified in USP 39 , Ph. Eur. 8.0 2.6.14 is used for pyrogenicity testing to achieve the Endotoxin limit of
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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Image /page/0/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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Orthovita, Inc. % Ms. Lia Gonzalez Senior Regulatory Affairs Specialist Stryker Corporation 2 Pearl Court Allendale, New Jersey 07401
Re: K161447
Trade/Device Name: HydroSet XT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: September 1, 2016 Received: September 2, 2016
Dear Ms. Gonzalez:
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.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, contributing to the legibility of the name.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161447
Device Name HydroSet XT
Indications for Use (Describe)
The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site.
HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support medium and is not intended to provide structural support during the healing process.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Traditional 510(k) Premarket Notification
| 510(k) Summary: HydroSet XT (K161447) | |
|---|---|
| Submitter: | Orthovita, Inc. |
| 45 Great Valley Parkway | |
| Malvern, PA 19355 | |
| Contact Person | Lia Gonzalez |
| Sr. Regulatory Affairs Specialist | |
| Stryker Spine | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Phone: 201-749-8699 | |
| E-mail: lia.gonzalez@stryker.com | |
| Date Prepared | September 1, 2016 |
| Trade Name | HydroSet XT |
| Common Name | Resorbable calcium salt bone void filler device |
| Proposed Class | Class II |
| Classification Name and | |
| Number | Filler, Bone Void, Calcium Compound |
| 21 CFR §888.3045 | |
| Syringe, Piston | |
| 21 CFR §880.5860 | |
| Product Code | MQV, FMF |
| Predicate Devices | Predicate Device: |
| Stryker Injectable Cement(K060061) | |
| ETEX MIXING AND DELIVERY SYSTEM(K141245) | |
| Device Description | HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre- |
| filled liquid syringe and a pre-filled powder syringe utilized for mixing and delivery of | |
| the cement. The device also includes the necessary components to prepare and deliver | |
| the cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). After | |
| preparation, the cement may be delivered by traditional plunger advancement or by | |
| rotating the threaded plunger to deliver the cement. | |
| Indications for Use | The Hydroset XT Mixing and Delivery System is intended to be used for the |
| delivery of Hydroset XT to an orthopedic surgical site. |
HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or
gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral
spine, and pelvis). These defects may be surgically created or osseous defects
created from traumatic injury to the bone. HydroSet XT is indicated only for bony
voids or gaps that are not intrinsic to the stability of the bony structure.
HydroSet XT cured in-situ provides an open void/gap filler that can augment
provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments
during the surgical procedure. The cured cement acts only as a temporary support
medium and is not intended to provide structural support during the healing process. |
| Summary of the
Technological
Characteristics | The subject device and the predicate device have similar technological characteristics
as the mixed powder and liquid components are identical and combine chemically in
identical fashion. Both devices are provided sterile and for single use only. Any
differences in mixing method do not raise new questions of safety or effectiveness. |
| Summary of Non-Clinical
Performance Testing | Performance testing was completed for HydroSet XT to determine its suitability for
use. The following tests were performed to evaluate the performance of HydroSetXT:
Working Time (Injectability and Torque) |
| 510(k) Summary: HydroSet XT (K161447) | |
| | Compression Setting Time (Wet Field Penetration Resistance) |
| | Bacterial endotoxin testing (BET) as specified in USP 39 , Ph. Eur. 8.0 2.6.14 is
used for pyrogenicity testing to achieve the Endotoxin limit of