(251 days)
Not Found
No
The description focuses on mechanical tissue interaction and data display, with no mention of AI/ML terms or capabilities.
Yes
The device is used to fragment or debride soft tissue during surgical procedures, which are therapeutic actions.
No
This device is described as a tool for fragmentation or debridement of soft tissue during surgical procedures. While an optional application displays real-time operating data, its primary function is mechanical interaction with tissue, not to diagnose a condition or disease.
No
The device description explicitly states it is a portable, handheld battery-powered device consisting of a Reusable Drive Unit, a charging station, and a sterile Disposable Unit that houses the cutting tool assembly, indicating it is a hardware device with an optional software component.
Based on the provided information, the Ocelot TDS 1000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fragmentation or debridement of soft tissue during surgical procedures." This describes a direct interaction with tissue within the body for therapeutic or surgical purposes.
- Device Description: The device is a "portable, handheld battery-powered device that consists of a Reusable Drive Unit (RDU), a charging station for the RDU, a sterile Disposable Unit (DU) that houses the cutting tool assembly, and an optional application that displays real-time operating data." This describes a surgical tool that mechanically interacts with tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The Ocelot TDS 1000 does not perform any such analysis of specimens.
The Ocelot TDS 1000 is clearly a surgical device intended for use in vivo (within the living body) to perform a physical action on tissue.
N/A
Intended Use / Indications for Use
The Ocelot TDS 1000 is indicated for use during surgical procedures when fragmentation or debridement of soft tissue is desired.
Product codes
LFL
Device Description
The Ocelot TDS 1000 is a portable, handheld battery-powered device that consists of a Reusable Drive Unit (RDU), a charging station for the RDU, a sterile Disposable Unit (DU) that houses the cutting tool assembly, and an optional application that displays real-time operating data. The Ocelot TDS 1000 is comprised of a unit that mechanically interacts with tissue and an app that provides real-time device operating data. A battery charging unit is provided to recharge the battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Testing was performed as follows:
- Software verification and validation
- Bench testing
- Design Verification Push and pull strength; cutting speed; drop test, functional testing.
- Bovine Muscle Tissue - Fragmentation or debridement comparison testing
- Comparative Cadaver testing
- Safety Tendon tissue damage comparison testing.
- Effectiveness - Tendon tissue fragmentation and debridement comparison testing.
- Comparative simulated irrigation and aspiration
- Safety Irrigation and aspiration of simulated calcific tendon material comparison testing
- Effectiveness Irrigation and aspiration of simulated calcific tendon material comparison testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2022
TendoNova Corporation % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K212049
Trade/Device Name: Oclet TDS 1000 Regulatory Class: Unclassified Product Code: LFL Dated: February 4, 2022 Received: February 7, 2022
Dear Paul Dryden:
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/cfpm/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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (0S) 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 mediation-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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212049
Device Name
Ocelot TDS 1000
Indications for Use (Describe)
The Ocelot TDS 1000 is indicated for use during surgical procedures when fragmentation or debridement of soft tissue is desired.
| 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) |
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 6
| Date Prepared: | 8-Mar-22 |
|---|---|
| TendoNova Corporation | |
| 3050 Business Park Drive, Ste A2 | |
| Norcross, Georgia 30071 | |
| Tel - (404) 376-6726 | |
| Official Contact: | Mark Samuels - CEO |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| 131 Bay Point Dr NE | |
| St. Petersburg, FL 33704 | |
| Proprietary or Trade Name: | Ocelot TDS 1000 |
| Common/Usual Name: | Instrument, Ultrasonic Surgical |
| Classification CFR: | Unclassified |
| Classification Code: | LFL |
| Classification Name: | Instrument, Ultrasonic Surgical |
| Class: | Unclassified |
| Predicate Device: | K153299, Tenex Tx1 |
| Common/Usual Name: | Instrument, Ultrasonic Surgical |
| Classification CFR: | Unclassified |
| Classification Code: | LFL |
| Classification Name: | Instrument, Ultrasonic Surgical |
| Class: | Unclassified |
Device Description:
The Ocelot TDS 1000 is a portable, handheld battery-powered device that consists of a Reusable Drive Unit (RDU), a charging station for the RDU, a sterile Disposable Unit (DU) that houses the cutting tool assembly, and an optional application that displays real-time operating data. The Ocelot TDS 1000 is comprised of a unit that mechanically interacts with tissue and an app that provides real-time device operating data. A battery charging unit is provided to recharge the battery.
Indications for Use:
The Ocelot TDS 1000 is indicated for use during procedures when fragmentation or debridement of soft tissue is desired.
4
Technological Characteristics Comparison:
| Subject Device: | Predicate Device | COMPARISON | |
|---|---|---|---|
| TendoNova Ocelot | Tenex Health TX System | ||
| Treatment Delivery System 1000 (TDS) | (K153299) | ||
| User Interface | Display Unit (Tablet) | Display Unit (Console) | Similar |
| User Interface | Handheld Tip (Battery Powered) | Handheld Tip (Cord) | Similar |
| Technology | Mechanically fragments and debrides tissue | ||
| at the target site | Ultrasonically fragments and debrides | ||
| tissue at the target site | The procedure is similar while the | ||
| frequency is different. | |||
| Controls | Adjustable Cutting Speed | Adjustable Cutting Power | Similar |
| Power delivery | Continuous | Continuous or Pulsed | Similar |
| Irrigation | Manual with Syringe (with optional luer) | Automatic with pump | Similar |
| Aspiration | Manual with Syringe (with optional Luer) | User selectable with Pump | Similar |
| Activation | Manual with Push button | Manual with foot switch | Similar |
| Tissue Interface Size | 18 Gauge Cannula | 18 Gauge Cannula | Identical |
| Tissue Cutting | Vibrating Cutting tip (mechanical) | Vibrating Cutting tip (Ultrasonic) | Similar |
| Handpiece | Disposable | Disposable | Similar |
| Power | 110 V AC mains to wireless battery charger | 110 V AC Mains to wired cord | Similar |
5
| Subject Device: | Predicate Device | COMPARISON | |
|---|---|---|---|
| TendoNova Ocelot | Tenex Health TX System | ||
| Treatment Delivery System 1000 (TDS) | (K153299) | ||
| Procedure time | Measures Cutting time | Measures Cutting time | Identical |
| Indications for Use | The Ocelot TDS 1000 is indicated for use | ||
| during procedures when fragmentation or | |||
| debridement of soft tissue is desired. | The Tenex Health TX System is indicated | ||
| for use in surgical procedures where | |||
| fragmentation, emulsification and | |||
| aspiration of soft tissue are desirable, | |||
| including General Surgery, Orthopedic | |||
| Surgery, Laparoscopic Surgery and Plastic | |||
| and Reconstructive Surgery. | The indications for use of the subject | ||
| device fall within the indication for use of | |||
| the predicate device | |||
| Components | Disposable Handheld cutting tip | Disposable Handheld Cutting Tip | Similar |
| Tablet with Display (optional) | Console with Display | Similar | |
| Optional Manual Irrigation and Aspiration | Inflatable cuff and pump for irrigation and | ||
| aspiration | Similar | ||
| Disposable Cutting Tip | Disposable Cutting tip | Similar | |
| Reusable Driver | Reusable Driver Console | Similar | |
| Mechanism of Action | Oscillating Needle 9 Hz to 27 Hz | Oscillating Needle – 25 kHz to 28 kHz | While the subject device's mechanism of |
| action is different from the predicate the | |||
| subject device shares a similar intended | |||
| use and has similar technological | |||
| characteristics as the predicate device |
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| Subject Device: | Predicate Device | COMPARISON | |
|---|---|---|---|
| TendoNova Ocelot | Tenex Health TX System | ||
| (K153299) | |||
| Treatment Delivery System 1000 (TDS) | |||
| Specifications | MicroTip needle: | ||
| Length: 30 mm to 84 mm | |||
| Outer Diameter: 18-gauge | |||
| Inner Needle: 22-gauge | MicroTip needle: | ||
| Length: 25.4 mm to 43.2mm | |||
| Outer Diameter: 18-gauge | |||
| Inner Needle: N/A | Similar | ||
| Tip Frequency: | |||
| 9 Hz to 25 Hz | Tip Frequency: | ||
| 25 kHz to 28 kHz | |||
| Power source: 100-240V, 50/60 Hz | Power source: 100-240V, 50/60 Hz | ||
| Cutting Tip Needle: | |||
| Needle Lengths: 30mm, 60mm, 84mm | |||
| Cutting travel distance: 2.5 +/- 0.5mm | Cutting Tip Needle: | ||
| Needle Lengths: 25.4mm, 58.4mm | |||
| Cutting travel distance: none | |||
| User Interface | Off-the-shelf Tablet has color LCD touch | ||
| screen with graphical user interface and | |||
| Reusable has LED display for power and | |||
| pairing information | Color LCD touch screen with graphical user | ||
| interface for selection of required settings. | Similar |
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Page 5 of 6
Difference Between Subject and Predicate
While both are handheld devices that fragment or debride soft tissue, there are some technological differences between the subject device and the predicate device (K153299). The key technological difference is that the subject device mechanically oscillates the cutting tip to fragment or debride tissue at the target site whereas the predicate device (K153299) ultrasonically oscillates the cutting tip to fragment or debride tissue. The predicate device (K153299) allows for irrigation of the target site to, for example, cool the ultrasonic tip. The subject device provides for optional manual irrigation using a syringe attached to the cannula. The Ocelot oscillates between 9 Hz and 25 Hz which is much lower than the predicate. The Ocelot does not require irrigation for cooling.
Substantial Equivalence Discussion
The subject device and predicate device (K153299) each are intended for fragmentation or debridement of soft tissue.
The subject device and the predicate (K153299) are comprised of similar device components. The subject device and predicate device both consist of a disposable handheld piece with an 18-gauge cannula. While the subject device's handheld piece is battery powered and the predicate device's handheld piece is connected via cord to the console, both devices use a needle to access a site and then using the needle, fragment tissue at the target site. The subject device's display unit showcases procedure time (however control is more conveniently located on the handpiece) and the display unit for the predicate device (K153299) identically showcases procedure time and provides control over the user functions. Although, subject device's display unit has slightly different functions than that of the predicate device, both display units are providing sufficient information to the user. Both devices are adjustable as to cutting frequency. The subject device and predicate device share similar dimensions of the cutting tip needle. Both device cutting tip needles are manufactured from 304 Stainless Steel (SS) and are 18-gauge. The subject device has cutting tip needle lengths which are similar to the lengths of the predicate device. The subject device's handheld piece can adjust the cutting speed and measure the cutting time, this is the same functionality as the predicate device 's adjustment of cutting power and measurement of cutting time. While the frequency at which the of the subject device's cutting tip needle oscillates is different to the predicate device's cutting tip needle, both devices use a rapidly moving cutting tip needle to fragment the soft tissue at the target site. The subject device's cutting tip needle mechanically oscillates while the predicate device ultrasonically oscillates, however, both the subject and predicate device cutting tip needle interacts with the tissue at the target site.
The subject device at user preference can manually irrigate and aspirate the target site via a syringe while the predicate device irrigates and aspirates the target site with an inflation cuff and foot pedal. The devices use different methods to perform this function, both devices share similar characteristics as they perform irrigation and aspiration as needed. Comparative testing demonstrated equivalent performance.
Sterilization
The Disposable Unit is provided sterile via Ethylene Oxide (EO). Sterilization was performed ISO 11135:2014/Amd.1:2018 Annex E, Half cycle approach. Clinical batch release using the overkill method, as outlined in Annex E of ISO 11135 that is intended to achieve a SAL of 10-6.
Biocompatibility
The subject device is considered as Surface Contact, breached tissue and of Limited Duration (