(141 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter for kyphoplasty, with no mention of AI or ML.
Yes
The device is intended for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty," which describes a direct medical intervention to treat a condition.
No
Explanation: The device is described as a "Vertebral Balloon" intended for "reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty." This indicates it is a therapeutic device used for physical intervention, not for diagnosing a condition.
No
The device description clearly outlines physical components such as a Y-connector, catheter, mandrel, and balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty." This is a surgical procedure performed in vivo (within the body) to treat vertebral fractures.
- Device Description: The description details a physical device (balloon, catheter, connectors) designed for mechanical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo as a surgical tool.
N/A
Intended Use / Indications for Use
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.
Product codes (comma separated list FDA assigned to the subject device)
HRX, NDN
Device Description
The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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)
The following testing was conducted to prove substantial equivalence with the predicate device (AVAmax Vertebral Balloon [K103064]):
- Unconstrained Burst Volume: Proposed device exceeds the predicates maximum rated volume before burst failure
- Constrained Burst Pressure: Proposed device exceeds the predicates maximum rated pressure while constrained
- Inflated Balloon Dimensions: Proposed inflated balloon dimensions are similar to the predicate device
- Deflation Time with Contrast Solution: Deflation time is similar to the predicate device of the same size and volume profile
- Tensile Force Testing: Device material and bond strengths are similar to the predicate device.
- Fatigue Testing: Proposed device must withstand three cycles of inflation at max psi.
No clinical testing was conducted for this submission.
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
§ 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.
0
August 12, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring an abstract symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
IZI Medical Products, LLC Qiang Cao Director of QA and RA 5 Easter Court, Suite J Owings Mills, Maryland 21117
Re: K200763
Trade/Device Name: Osteo-site® Vertebral Balloon Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: June 29, 2020 Received: July 2, 2020
Dear Qiang Cao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200763
Device Name Osteo-site® Vertebral Balloon
Indications for Use (Describe)
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of a void in cancellous bone in the spine for Kyphoplasty.
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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3
Image /page/3/Picture/2 description: The image shows the logo for IZI Medical. The logo consists of two overlapping hexagons, one orange and one yellow. To the right of the hexagons is the text "IZI Medical" in a simple, sans-serif font. The text is black and the logo is set against a white background.
Submitter
| Submitter Name: | IZI Medical Products LLC |
|---|---|
| Submitter Address: | 5 Easter Court, Suite J |
| Owings Mills, MD 21131 | |
| Telephone Number: | (410) 594-9403 |
| Fax Number: | (410) 594-0540 |
| Contact Person: | Qiang Cao |
| Registration Number: | 1123169 |
Device Name:
| Trade Name: | Osteo-site® Vertebral Balloon |
|---|---|
| Common or Usual Name: | Vertebral Balloon |
| Primary Classification Name: | Cement, Bone Vertebroplasty (21 CFR §888.3027, Product Code NDN) |
| Secondary Classification Name: | Arthroscope (21 CFR §888.1100, Product Code HRX) |
Predicate Devices:
- AVAMax Vertebral Balloon [K103064]
- . Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters [K172214]
Device Description
The Osteo-site® Vertebral Balloon consists of a Y-connector with luer fitting, catheter with mandrel, and a balloon with radiopaque markers. The Y-connector is adhered to a strain relief fitting which is then adhered to the proximal end of the outer shaft. The mandrel ball is placed in a socket at the proximal end of the Y-connector that is coaxial to the catheter. The distal end of the catheter is welded to the proximal end of the balloon and the distal end of the mandrel is screwed into the distal end of the balloon. This construction allows for fluid to fill from the angled section of the Y-connector, around the mandrel, and into the balloon without obstruction. The mandrel can move freely longitudinally until the ball end meets the limits of the socket at the proximal end of the Y-connector. This controls the balloon expansion longitudinally. The radiopaque markers at the distal end of the mandrel are an imaging reference of balloon placement for the user. The proximal markers are visual indication of the balloon's placement. The exterior surface of the balloon is covered by a lubricant which eases access through the introducer cannula.
4
Indications for use
The Osteo-site® Vertebral Balloon is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for Kyphoplasty.
Technological Characteristics
The design and technological characteristics of the predicate AVAmax balloon are substantially equivalent to the proposed Osteo-site® Vertebral Balloon.
Both the proposed and predicate device use the same technological characteristics for creation of the void within bone. Both devices use radio fluorescent markers to identify placement of the device. In both cases contrast is used to inflate a polyurethane balloon in order to compress cancellous bone within the vertebral body. Lastly, in both cases the contrast is delivered through a luer connector at the proximal end of the balloon and the contrast flows along a catheter shaft until reaching the balloon at the distal end of the assembly.
| Technological Comparison | |||
|---|---|---|---|
| Description | Osteo-site® | ||
| Vertebral Balloon | Predicate AVAmax | ||
| [K103064] | Predicate Modified | ||
| Winch [172214] | |||
| Prescription/over the | |||
| counter use | Prescription | Prescription | Prescription |
| Sterilization Method | EO | EO | EO |
| Balloon size | 15mm | 15mm | 15mm |
| Max Balloon Volume | 4mL | 4mL | 4mL |
| Max Inflation | |||
| Pressure | 400 psi | 400 psi | 400 psi |
| Siliconization | Yes | No | Yes |
| Packaging | |||
| configuration | Tyvek sealed tray | ||
| within Tyvek pouch | Tyvek sealed tray | Tyvek pouch | |
| Markers | Platinum/Iridium | Platinum/Iridium | Platinum/Iridium |
| Catheter length | 240mm | 189mm | 241mm |
| Balloon Material | Polyurethane | Polyurethane | Polyurethane |
| Catheter Material | Polyurethane | Polyurethane | Polyurethane |
The design and technological characteristics of the predicate AVAmax and Modified Winch balloons are substantially equivalent to the proposed Osteo-site® Vertebral Balloon.
Performance Testing
The following testing was conducted to prove substantial equivalence with the predicate device (AVAmax Vertebral Balloon [K103064]).
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| Test Performed | Acceptance Criteria |
|---|---|
| Unconstrained Burst Volume | Proposed device exceeds the predicates |
| maximum rated volume before burst | |
| failure | |
| Constrained Burst Pressure | Proposed device exceeds the predicates |
| maximum rated pressure while | |
| constrained | |
| Inflated Balloon Dimensions | Proposed inflated balloon dimensions are |
| similar to the predicate device | |
| Deflation Time with Contrast Solution | Deflation time is similar to the predicate |
| device of the same size and volume | |
| profile | |
| Tensile Force Testing | Device material and bond strengths are |
| similar to the predicate device. | |
| Fatigue Testing | Proposed device must withstand three |
| cycles of inflation at max psi. |
No clinical testing was conducted for this submission.
Sterilization and Shelf-Life
The device will be ETO sterilized. The Sterility Assurance Level (SAL) is 10 °.
The device has a shelf-life of 12 months based on an accelerated aging study.
Biocompatibility
The biocompatibility evaluation for the Osteo-site® Vertebral Balloon was conducted in accordance with ISO-10993-1, Biological Evaluation of Medical Devices. Testing included the following:
- Cytotixicity ●
- Irritation ●
- Sensitization
- Pyrogenicity ●
- . Systemic Toxicity
The Osteo-site® Vertebral Balloon is considered indirect blood contacting for a duration of less than 24 hours.
Summary of Substantial Equivalence
Based on the indications for use, intended use, design, safety and performance testing, the proposed Osteo-site® Vertebral Balloon meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate Devices, AVAmax Vertebral
6
Balloon [K103064] and Modified Winch Kyphoplasty (15 And 20 Mm) 11 Gauge Balloon Catheters [K172214].