(174 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a balloon catheter, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections explicitly state "Not Found" or "Not Applicable".
Yes
It is used for the reduction and fixation of fractures and creating a void in cancellous bone in the spine during balloon kyphoplasty, which are therapeutic medical interventions.
No
The device is a balloon catheter primarily used for reduction and fixation of fractures and/or creation of a void in cancellous bone. Its intended use and description focus on a therapeutic procedure (kyphoplasty) rather than diagnosing a condition.
No
The device description clearly states it is a physical balloon catheter, a single-use disposable sterile device with a balloon at the distal end, and describes its physical components and mechanical testing. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The RENOVA SPINE BALLOON CATHETER is a surgical tool used within the body during a procedure (balloon kyphoplasty) to physically manipulate bone. It does not analyze samples or provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine." This is a therapeutic/surgical intervention, not a diagnostic one.
The device description and performance studies further confirm its nature as a physical medical device used in a surgical procedure, not for in vitro testing.
N/A
Intended Use / Indications for Use
RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
Product codes (comma separated list FDA assigned to the subject device)
NDN, HRX
Device Description
The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm.
RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end.
The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device.
The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.
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)
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility
- Packaging shelf life accelerated aging tests
- Performance/Functionality/Safety
- . EO Sterilization Validation
In particular, performance mechanical tests included:
- Balloon Deflation Time
- . Burst Pressure
- Fatigue Strength
- Unconstrained Burst Strength
- Inflated Dimensions
- Tensile Bond Strength
- Insertion and Withdrawal Force
Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
October 30, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Biopsybell s.r.l. % Maurizio Pantaleoni Senior Consultant Maytal Doo Kneza Milosa. 79 Belgrade, Serbia 11000
Re: K231340
Trade/Device Name: Renova Spine Balloon Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, HRX Dated: September 29, 2023 Received: September 29, 2023
Dear Maurizio Pantaleoni:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jesse Muir J Digitally signed by
Jesse Muir J Jesse Muir -S Date: 2023.10.30 S 13:39:55 -04'00' Jesse Muir, Ph.D. Assistant Director DHTC: 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
Indications for Use
510(k) Number (if known) K231340
Device Name RENOVA SPINE BALLOON CATHETER
Indications for Use (Describe)
RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
| 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
1. General Information
| Submitter: | Biopsybell srl is located at |
|---|---|
| Via A. Manuzio n.24 | |
| 41037, Mirandola (MO) | |
| ITALY |
Establishment Registration Number: 9617616
| Contact: | Maurizio Pantaleoni |
|---|---|
| Maytal Doo | |
| Kneza Miloza 79 | |
| 11000 Beograd (Serbia) | |
| Tel. +381 11 3340700 | |
| Mob. +39 3484435155 | |
| Email: regulatory@maytal.eu |
Summary Preparation Date: April 24th, 2023
2. Name & Classification
| Device Name: | RENOVA SPINE BALLOON CATHETER |
|---|---|
| Regulation Name: | PMMA bone cement |
| Regulation Number: | 888.3027 |
| Product Code: | NDN, HRX |
| CLASS: | II |
3. Predicate Devices
The RENOVA SPINE BALLOON CATHETER is substantially equivalent to the following device:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| PAN MEDICAL | ||
| LTD | InterV Kyphoplasty Catheter and InterV | |
| Kyphoplasty Catheter (Mini) | K150322 |
4. Indications for Use
RENOVA SPINE BALLOON CATHETER is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
4
5. Device Description
The RENOVA SPINE BALLOON CATHETER is a single use disposable sterile device available in 3 different models depending on the dimensions of the balloon: 10 mm, 15 mm and 20 mm.
RENOVA SPINE BALLOON CATHETER is a single use catheter (double lumen tube) with a balloon at the distal end.
The balloon catheter is normally inserted through a needle / working cannula and inflated through an inflation device.
The catheter has two separate lumens connected to a Y connector at the proximal end of the catheter. The outer lumen of the catheter is used to inflate the balloon while the central lumen contains a removable stylet used to aid in the introduction of the balloon catheter.
6. Comparison with the predicate devices
| Subject device | Predicate device (K150322) | |
|---|---|---|
| Device | RENOVA SPINE BALLOON CATHETER | InterV Kyphoplasty Catheter and |
| InterV Kyphoplasty Catheter (Mini) | ||
| (K150322) | ||
| 510(K) number | - | |
| Applicant | BIOPSYBELL S.R.L. | PAN MEDICAL LTD. |
| Classification | ||
| Reg. Number | 888.3027 PMMA bone cement | 888.3027 PMMA bone cement |
| 888.1100 Arthroscope | ||
| Product Code | NDN | |
| HRX | NDN | |
| HRX | ||
| Regulatory Class | II | II |
| Intended use | ||
| Intended use | RENOVA SPINE BALLOON CATHETER | |
| is intended to be used for reduction | ||
| and fixation of fractures and/or | ||
| creation of a void in cancellous bone | ||
| in the spine during balloon | ||
| kyphoplasty (for use with cleared | ||
| spinal polymethymethacrylate | ||
| (PMMA) bone cements). | InterV Kyphoplasty Catheter is | |
| intended to be used for reduction | ||
| and fixation of fractures and/or | ||
| creation of a void in cancellous bone | ||
| in the spine during balloon | ||
| kyphoplasty (for use with cleared | ||
| spinal polymethymethacrylate | ||
| (PMMA) bone cements). | ||
| Subject device | Predicate device (K150322) | |
| Mechanism of | ||
| Action / Mode | ||
| of Action | The balloon is designed to compress | |
| cancellous bone and/or move cortical | ||
| bone as it inflates |
The balloon catheter is normally
inserted through a needle. Once in
place, a hydraulic expansion is
performed (ie the balloon is filled
with liquid). After removing the
balloon the space created is filled
with bone cement. | The balloon is designed to compress
cancellous bone and/or move
cortical bone as it inflates |
| Design Features | | |
| Single Use
Device | YES | YES |
| Configuration of
device | Double lumen catheter with a
removable stylet and a balloon at the
distal end and an Y connector at the
proximal end. | InterV Kyphoplasty Catheter come as
a single-use double lumen catheter
with a low profile balloon mounted
on the distal tip. |
| Dimensions
(Balloon length -
deflated) | 10 mm
15 mm
20 mm | 10 mm
15 mm
20 mm |
| Compatible
Cannula Size | Cannula with diameter:
3,1 mm | Cannula with diameter:
3 mm |
| Performances
(Max inflation
pressure) | 27 ATM (400 psi) | 50 ATM ( 750 psi) |
| Materials | | |
| Balloon | Polyurethane | Polyurethane |
| Catheter | Polyurethane | Polyurethane |
| Stylet | AISI 304 stainless steel | Stainless steel |
| Biocompatibility | | |
| Standard | Compliant to ISO 10993-1: | Not known |
| Sterilization
Shelf life | | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
| Shelf life | 3 years | 3 years |
| Performance
test for
determination
of the SE | | |
| Performance
tests | Performance tests have been
performed on the device, in
comparison with predicate device | Performance tests have been
performed on the device, in
comparison with predicate device |
5
6
7. Performance Data
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility
- Packaging shelf life accelerated aging tests
- Performance/Functionality/Safety
- . EO Sterilization Validation
In particular, performance mechanical tests included:
- Balloon Deflation Time
- . Burst Pressure
- Fatigue Strength
- Unconstrained Burst Strength
- Inflated Dimensions
- Tensile Bond Strength
- Insertion and Withdrawal Force
Results of the evaluations demonstrate that the subject device met the safety and performance requirements as per its indication for use.
8. Clinical data
N/A
9. Conclusions
In light of evidences summarized above and based on classification, intended use, technological characteristics and performance data, the subject device is substantially equivalent to the predicate device.