The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Device Description

The Kyphon® Express™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are a coaxial dual lumen shaft. Y .- Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.

AI/ML Overview

The Kyphon® Express™ II Inflatable Bone Tamp (K123771) received 510(k) clearance based on substantial equivalence to a predicate device, the KYPHON Xpander™ II Inflatable Bone Tamp (K101864). This type of submission does not typically involve the rigorous clinical trials or standalone performance studies often seen with novel devices or AI/software as a medical device (SaMD). Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as a legally marketed predecessor through non-clinical testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Summary from K123771)
Technological Characteristics	The fundamental scientific technology, design characteristics, materials of construction, packaging, and sterilization process should be identical or equivalent to the predicate device.	"The fundamental scientific technology of the subject Kyphon® Express™ II Inflatable Bone Tamps is identical to the predicate KYPHON Xpander™ II Inflatable Bone Tamps.""The Kyphon® Express™ II Inflatable Bone Tamps have the same design characteristics, packaging, use the same sterilization process, and are made of equivalent materials as the predicate KYPHON Xpander™ II Inflatable Bone Tamps.""The subject and predicate Inflatable Bone Tamps are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics."
Indications for Use (IFU)	The IFU must be the same as the predicate device.	The IFU for the Kyphon® Express™ II Inflatable Bone Tamps explicitly states: "The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus," indicating alignment with the predicate.
Performance Specifications/Safety & Effectiveness	The device must function as intended and not raise new issues of safety or effectiveness. This is typically assessed through mechanical testing and other verification/validation activities.	"Mechanical testing and other verification/validation activities, including tolerance analyses were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.""A risk analysis and associated verification/validation testing was completed for the device modifications."
Substantial Equivalence Conclusion	Based on the above, a conclusion of substantial equivalence to a legally marketed predicate device must be drawn.	"Medtronic believes the subject Kyphon® Express™ II Inflatable Bone Tamps to be substantially equivalent to the legally marketed predicate KYPHON Xpander™ II Inflatable Bone Tamps." The FDA concurred with this assessment in their letter.

The study that proves the device meets the acceptance criteria is detailed in the section "X. Brief Discussion of the Non-Clinical Tests Submitted":

Nature of the Study: This was a non-clinical testing and verification/validation study. It focused on comparing the new device (Kyphon® Express™ II) to its predicate (KYPHON Xpander™ II) based on their design, materials, manufacturing processes, and functional performance. It specifically mentions "Mechanical testing and other verification/validation activities, including tolerance analyses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a "sample size" in the context of human subjects or clinical data for a test set, as this was a non-clinical comparison for substantial equivalence. The "sample size" would refer to the number of devices or components tested in the mechanical and verification/validation studies, which is not detailed in the summary.
Data Provenance: Not applicable in the context of country of origin for clinical data, as this was a non-clinical submission relying on engineering and design control data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This was a 510(k) submission based on substantial equivalence via non-clinical testing. It did not involve establishing ground truth from clinical experts for a test set in the way an AI/SaMD would. The "experts" involved would be Medtronic's internal engineering and regulatory personnel who performed and reviewed the design and testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There was no "test set" in the context of clinical data requiring expert adjudication.

5. 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

No. This type of study is entirely irrelevant to a 510(k) submission for an inflatable bone tamp based on substantial equivalence. This device is a manual surgical instrument, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or software device. It is a physical medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Non-Clinical "Ground Truth": For this submission, the "ground truth" was established by comparing the Kyphon® Express™ II's engineering specifications, material properties, design characteristics, and mechanical performance against those of the predicate device (KYPHON Xpander™ II). The "truth" to be established was that the new device performs equivalently and safely, as confirmed by internal Medtronic testing and risk analysis, to its legally marketed predecessor.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of machine learning for this device. The development process involved engineering design, material selection, and mechanical testing, not algorithm training.

9. How the ground truth for the training set was established

Not Applicable. No training set, thus no ground truth for a training set to be established.

Summary

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K12377

Kyphon® Express™ II Inflatable Bone Tamp 510(k) Summarv December 6, 2012

DEC 2 1 2012

I. Company:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132Telephone: (901) 396-3133FAX: (901) 346-9738
II. Contact:	Hetal Jawahar ThakkerSenior Regulatory Affairs Specialist
III. Proprietary Trade Name:	Kyphon® Express™ II Inflatable Bone Tamp
IV. Common Name:	Inflatable Bone Tamp
V. Classification Name:	Arthroscope (21CFR888.1100)Orthopedic Manual Surgical Instrument (21CFR 888.4540)
Class:	II
Product Code:	HRX, HXG

VI. Product Description

VII. Indications for Use

VIII. Summary of Technological Characteristics

The fundamental scientific technology of the subject Kyphon® Express™ II Inflatable Bone Tamps is identical to the predicate KYPHON Xpander™ II Inflatable Bone Tamps.

Both the subject Kyphon® Express™ II Inflatable Bone Tamps and predicate KYPHON Xpander™ II Inflatable Bone Tamps consist of shaft, Y-Adapter and the inflatable balloon located at the distal tip. The Inflatable Bone Tamp is connected to an inflation syringe in order to inflate/deflate the balloon. Two radiopaque markers located at the distal and proximal end of the deflated balloon allow fluoroscopic visualization of the IBT during positioning prior to inflation. Once positioned, the balloon is inflated with contrast-media solution to create a cavity in the vertebral body, which may be subsequently filled with bone cement.

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IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence

In order to demonstrate substantial equivalence to legally marketed predicate devices, KYPHON Xpander™ II Inflatable Bone Tamp (K101864, SE Oct 14, 2010) is used as the predicate for the Kyphon® Express™ II Inflatable Bone Tamps.

X. Brief Discussion of the Non-Clinical Tests Submitted

Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The Kyphon® Express™ II Inflatable Bone Tamps have the same design characteristics, packaging, use the same sterilization process, and are made of equivalent materials as the predicate KYPHON Xpander™ II Inflatable Bone Tamps. Mechanical testing and other verification/validation activities, including tolerance analyses were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.

XI. Conclusions Drawn from the Non-Clinical Tests

The subject and predicate Inflatable Bone Tamps are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics. A risk analysis and associated verification/validation testing was completed for the device modifications. Based on the risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject Kyphon® Express™ II Inflatable Bone Tamps to be substantially equivalent to the legally marketed predicate KYPHON Xpander™ II Inflatable Bone Tamps.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic % Medtronic Spine, LLC Hetal Jawahar Thakker Senior Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089

Re: K123771

Trade/Device Name: Kyphon® Express™ II Inflatable Bone Tamps Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: December 6, 2012 Received: December 7, 2012

Dear Hetal Jawahar Thakker:

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

December 21, 2012

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Page 2 - Hetal Jawahar Thakker

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/CDRH/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,

Peter D. Rumm -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Kyphon® Express™ II Inflatable Bone Tamps

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division of Orthopedic Devices : iu(k) Number_ 1237

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.