(84 days)
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
The Kyphon® Inflation Syringe consists of a syringe barrel; a threaded plunger assembly with a depress-release handle; a digital display that provides pressure readout; an outer shell assembly that retains the internal components; a flexible tubing designed to withstand high inflation pressures; and a weighted swivel-luer for connection to the inflatable device (including Inflatable Bone Tamps). The device is designed to generate and monitor pressures up to 700psi (providing the user the option to be able to select the Maximum Inflation Pressure of 400psi or 700psi depending on the inflatable device being used). The Locking Syringe (to be packaged together with the Inflation Syringe) is a 30ml polycarbonate syringe and is included for preparation of the inflatable device, as necessary. A V-Klip™ (available as part of the 2 Pack configuration) holds two Kyphon Inflation Syringes for concurrent dual-syringe operation.
Here's an analysis of the Kyphon® Inflation Syringe based on the provided document, addressing your questions about acceptance criteria and the supporting study:
Disclaimer: This response is based solely on the provided text. The document is a 510(k) summary, which often provides general statements about testing rather than detailed study protocols and results. Therefore, specific numerical acceptance criteria and granular study details are largely absent in this type of document.
Acceptance Criteria and Device Performance
Based on the provided K103231 510(k) summary, the acceptance criteria are generally framed around demonstrating substantial equivalence to a predicate device and meeting specifications and performance characteristics. Specific numerical targets for acceptance criteria are not explicitly stated in this summary.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Functional and Mechanical Performance: The device must reliably inflate and deflate inflatable devices and accurately measure pressure within those devices, up to specified maximums (400psi or 700psi). | "Testing of the Kyphon® Inflation Syringe was completed to demonstrate that the device meets the specifications and performance characteristics, and is substantially equivalent to the predicate devices. The testing included functional and mechanical testing." "The device is designed to generate and monitor pressures up to 700psi (providing the user the option to be able to select the Maximum Inflation Pressure of 400psi or 700psi depending on the inflatable device being used)." "The products have the same fundamental scientific technology and basic design, and similar intended use and functional characteristics as the predicate Inflation Syringe." "The results of testing demonstrate that the Kyphon® Inflation Syringe is safe and effective for its intended use." |
| Biocompatibility: The materials used in the device must be safe for patient contact. | "Biocompatibility testing of the Kyphon® Inflation Syringe confirmed that the devices meet applicable requirements of the FDA Blue Book Memorandum #G95-1 entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and are biocompatible." |
| Sterilization Efficacy: The sterilization process must render the device sterile. | "Sterilization validation were completed." "The Kyphon® Inflation Syringe will be provided sterile and is intended for single use only." |
| Packaging and Labeling Integrity: The packaging must maintain sterility and protect the device, and labeling must be accurate and adequate. | "The components are placed in an inner and outer polyethylene terephthalate glycol (PETG) Tray with a Tray lid. This configuration is sealed with a Tyvek® Lid, and placed in a carton." (While testing isn't explicitly detailed, successful packaging implies meeting protectiveness and sterility barrier goals). "Labeling" is mentioned as a general control provision requirement by the FDA, implying its review and acceptance. |
| Substantial Equivalence: The device must be demonstrated to be as safe and effective as the predicate device (Atrion Medical QL® Inflation Device: K032840). | "The information submitted in this pre-market notification supports a determination that the Kyphon® Inflation Syringe is substantially equivalent to the predicate devices, the Atrion Medical QL Inflation Device cleared under K032840. The products have the same fundamental scientific technology and basic design, and similar intended use and functional characteristics as the predicate Inflation Syringe." |
Study Details
Given that this is a 510(k) summary for a medical device that appears to be a mechanical instrument and not an AI/software device, many of the typical questions for AI medical devices (like training/test sets, ground truth experts, MRMC studies, standalone performance) are not applicable or detailed in this document. The "study" mentioned refers to the engineering and biocompatibility testing required for a mechanical device.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: The testing was conducted internally by Medtronic Spine LLC. There is no indication of external data sources or countries of origin. It would be considered prospective engineering and biocompatibility testing rather than retrospective data analysis.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For a mechanical device like an inflation syringe, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards (e.g., ISO 10993 for biocompatibility) rather than expert consensus on interpretive data. The "experts" would be the engineers, toxicologists, and quality assurance personnel responsible for conducting and verifying the tests.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., image reading) where consensus is needed for ground truth. For mechanical testing, results are typically objective measurements against a defined specification.
-
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 is a mechanical device, not an AI or imaging device, so MRMC studies are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm, nor is it an AI device. The device is a tool operated by a human user.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and regulatory standards. For functional and mechanical testing, the ground truth would be that the device operates within its specified pressure range, holds pressure, and inflates/deflates as intended. For biocompatibility, the ground truth is compliance with ISO 10993. For sterilization, the ground truth is a Sterility Assurance Level (SAL) validated through a sterilization cycle. These are objective measures against predefined criteria.
-
The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set. The device itself is the product being tested.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this device.
{0}------------------------------------------------
K(0323/
Traditional 510(k) Submission
Medtronic Spine LLC Page 1 of 2, Tab 5
Tab 5 PREMARKET NOTIFICATION [510(k)] SUMMARY
| Summary Date | January 10, 2011 | JAN 24 2011 |
|---|---|---|
| Trade Name: | Kyphon® Inflation Syringe | |
| Common Name: | ArthroscopeTamp | |
| Classification Name: | Class II, Arthroscope, 21 CFR 888.1110Class I, Orthopedic Manual Surgical Instrument, 21 CFR 888.4540 | |
| Device Code: | HRXHXG | |
| Manufacturer's Name: | Medtronic Spine LLC | |
| Address: | 1221 Crossman AvenueSunnyvale, CA 94089 | |
| Contact Person: | Hetal Jawahar Thakker | |
| Title: | Sr Regulatory Affairs Specialist | |
| Address: | 1221 Crossman AvenueSunnyvale, CA 94089 | |
| Phone: | (408) 548-5334 | |
| Predicate Device(s): | Atrion Medical QL® Inflation Device: K032840 (cleared on March 03, 2004) | |
| Intended Use | The Kyphon® Inflation Syringe is intended to be used to inflate and deflateinflatable devices (including Inflatable Bone Tamps) and to measure the pressurewithin the inflatable device during the procedure. | |
| Device Description: | The Kyphon® Inflation Syringe consists of a syringe barrel; a threaded plungerassembly with a depress-release handle; a digital display that provides pressurereadout; an outer shell assembly that retains the internal components; a flexibletubing designed to withstand high inflation pressures; and a weighted swivel-luerfor connection to the inflatable device (including Inflatable Bone Tamps).The device is designed to generate and monitor pressures up to 700psi (providingthe user the option to be able to select the Maximum Inflation Pressure of 400psi or700psi depending on the inflatable device being used). |
{1}------------------------------------------------
| Medtronic Spine LLCPage 2 of 2, Tab 5 | Traditional 510(k) SubmissionKyphon® Inflation Syringe | ||
|---|---|---|---|
| The Locking Syringe (to be packaged together with the Inflation Syringe) is a 30mlpolycarbonate syringe and is included for preparation of the inflatable device, asnecessary. | |||
| A V-Klip™ (available as part of the 2 Pack configuration) holds two KyphonInflation Syringes for concurrent dual-syringe operation. | |||
| Testing | Testing of the Kyphon® Inflation Syringe was completed to demonstrate that thedevice meets the specifications and performance characteristics, and issubstantially equivalent to the predicate devices. The testing included functionaland mechanical testing. In addition, biocompatibility testing and sterilizationvalidation were completed. | ||
| Biocompatibility | Biocompatibility testing of the Kyphon® Inflation Syringe confirmed that thedevices meet applicable requirements of the FDA Blue Book Memorandum #G95-1 entitled "Use of International Standard ISO-10993, "Biological Evaluation ofMedical Devices Part-1: Evaluation and Testing" and are biocompatible. | ||
| Sterilization | The Kyphon® Inflation Syringe will be provided sterile and is intended for singleuse only. | ||
| Packaging andLabeling | The components are placed in an inner and outer polyethylene terephthalate glycol(PETG) Tray with a Tray lid. This configuration is sealed with a Tyvek® Lid, andplaced in a carton. | ||
| SubstantialEquivalence: | The information submitted in this pre-market notification supports a determinationthat the Kyphon® Inflation Syringe is substantially equivalent to the predicatedevices, the Atrion Medical QL Inflation Device cleared under K032840. Theproducts have the same fundamental scientific technology and basic design, andsimilar intended use and functional characteristics as the predicate InflationSyringe.The results of testing demonstrate that the Kyphon® Inflation Syringe is safe andeffective for its intended use. |
:
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Spine, LLC % Hetal Jawahar Thakker Senior Regulatory Affairs Specialist 1211 Crossman Avenue Sunnyvale, California 94089
Re: K103231
Trade/Device Name: Kyphon® Inflation Syringe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG Dated: October 29, 2010 Received: November 1, 2010
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
JAN 2 4 250
{3}------------------------------------------------
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/Reportal?roblem/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,
g B-R
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Tab 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Kyphon® Inflation Syringe
Indications for Use:
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
signature
(Division Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103231
§ 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.