HydroSet XT by ORTHOVITA, INC. | FDA 510(k) Summary

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "HydroSet XT". This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for an AI/ML device. Therefore, the requested information elements related to AI model evaluation (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this document.

However, I can extract the relevant information regarding the non-clinical performance testing conducted for the HydroSet XT device, which serves as the "study" proving the device meets certain acceptance criteria.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

The document does not explicitly state numerical acceptance criteria for "Working Time" or "Compression Setting Time." Instead, it indicates that "Performance testing was completed for HydroSet XT to determine its suitability for use," and "The following tests were performed to evaluate the performance of HydroSetXT." The conclusion states that the device "demonstrated substantial equivalence" based on this performance testing, implying that the results met the criteria for suitability and equivalence.

Therefore, the table will reflect the tests performed and the implied "acceptance" through the substantial equivalence claim, rather than specific numerical criteria and results.

Acceptance Criteria (Implied)	Reported Device Performance
Suitability for use regarding Working Time (Injectability and Torque)	Performance testing completed; deemed suitable for use.
Suitability for use regarding Compression Setting Time (Wet Field Penetration Resistance)	Performance testing completed; deemed suitable for use.
Pyrogenicity for bacterial endotoxin limit (<20 EU/Device)	Bacterial endotoxin testing (BET) performed as specified in USP 39 <85>, Ph. Eur. 8.0 2.6.14. Based on an endotoxin limit of 20 EU/Device.

Detailed Information about the "Study" (Non-Clinical Performance Testing):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document for each test.
- Data Provenance: Not specified, but generally, such testing is conducted in a laboratory setting by the manufacturer. It is non-clinical, not patient-derived data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a bone void filler, and the described tests are physical/chemical performance evaluations, not diagnostic assessments requiring clinician ground truth.
Adjudication method for the test set:
- Not applicable. The tests performed are objective measurements of physical properties (e.g., working time, setting time, endotoxin levels), not subjective assessments requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is for a medical device (bone void filler) and does not involve AI or human reader interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used:
- For the non-clinical performance tests (Working Time, Compression Setting Time): The "ground truth" is established by standard laboratory testing methodologies and specifications for these physical/chemical properties.
- For Bacterial Endotoxin Testing (BET): The "ground truth" is a Pass/Fail criterion based on the specified endotoxin limit (<20 EU/Device) as per pharmacopoeial guidelines (USP 39 <85>, Ph. Eur. 8.0 2.6.14).
The sample size for the training set:
- Not applicable. The described testing is not for an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.

Summary

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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,

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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.

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 ParkwayMalvern, PA 19355
Contact Person	Lia GonzalezSr. Regulatory Affairs SpecialistStryker Spine2 Pearl CourtAllendale, NJ 07401Phone: 201-749-8699E-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 andNumber	Filler, Bone Void, Calcium Compound21 CFR §888.3045Syringe, Piston21 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 ofthe cement. The device also includes the necessary components to prepare and deliverthe cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). Afterpreparation, the cement may be delivered by traditional plunger advancement or byrotating the threaded plunger to deliver the cement.
Indications for Use	The Hydroset XT Mixing and Delivery System is intended to be used for thedelivery of Hydroset XT to an orthopedic surgical site.HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids orgaps of the skeletal system (i.e. extremities, craniofacial, posterolateralspine, and pelvis). These defects may be surgically created or osseous defectscreated from traumatic injury to the bone. HydroSet XT is indicated only for bonyvoids 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 augmentprovisional hardware (e.g. k-wires, plates, screws) to help support bone fragmentsduring the surgical procedure. The cured cement acts only as a temporary supportmedium and is not intended to provide structural support during the healing process.
Summary of theTechnologicalCharacteristics	The subject device and the predicate device have similar technological characteristicsas the mixed powder and liquid components are identical and combine chemically inidentical fashion. Both devices are provided sterile and for single use only. Anydifferences in mixing method do not raise new questions of safety or effectiveness.
Summary of Non-ClinicalPerformance Testing	Performance testing was completed for HydroSet XT to determine its suitability foruse. 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 <85>, Ph. Eur. 8.0 2.6.14 isused for pyrogenicity testing to achieve the Endotoxin limit of <20EU/Device. Basedon an endotoxin limit of 20 EU/Device and an extraction volume of 40 mltheMaximum Valid Dilution (MVD) will be a 1:50 dilution.
Conclusions	Based upon a comparison of intended use, technological characteristics and deviceperformance in the non-clinical tested listed above, HydroSet XT has demonstratedsubstantial equivalence to its predicate device.

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Regulation Number and Section

§ 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.