(50 days)
No
The device description and performance studies focus on mechanical manipulation and vacuum application, with no mention of AI/ML terms or functionalities.
No
The device is described as an assist device for establishing pneumoperitoneum during laparoscopic procedures, primarily for manipulating tissue around the Veress needle insertion site, which is a surgical aid rather than a direct treatment for a disease or condition.
No
Explanation: The device description states its purpose is to "manipulate (hold and pull on) the tissue around the Veress needle insertion site" for pneumoperitoneum establishment, and its "Intended Use / Indications for Use" focuses on assisting in this procedure. There is no mention of the device analyzing data or providing information about a patient's medical condition or disease.
No
The device description clearly outlines physical components such as a pad with suction cups, a port for a vacuum line, a button, and a handle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the establishment of a pneumoperitoneum during laparoscopic procedures by manipulating tissue around the Veress needle insertion site. This is a surgical assist device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical device with suction cups, a vacuum port, a button, and a handle for manipulating tissue. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the TauTona Pneumoperitoneum Assist Device (TPAD) is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the Veress Needle for the establishment of a pneumoperitoneum during laparoscopic procedures.
Product codes
HIF
Device Description
The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, Palmer's Point, umbilical regions
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)
Clinical Data:
The clinical study was performed in two phases. The first phase included 20 patients and evaluated the TPAD vs. Standard of Care (SOC) for patients undergoing laparoscopic surgery where the Veress Needle was used to establish a pneumoperitoneum (see K233020). The majority of Veress entries were in the upper left quadrant (i.e. Palmer's point). The second phase of the study included 10 patients and focused on the umbilical region of the abdominal wall. In both phases the studies compared satisfaction, time, and skin impacts. The primary endpoint of the average surgeon questionnaire scoring was not significantly different for SOC and TPAD across all responses. The average timing measurements from the incision to Veress Needle Insertion, as well as time from incision to insufflation, were not significantly different between SOC and TPAD for both timing durations. The average patient questionnaire scoring was not significantly different for SOC and TPAD across all responses. No Severe or Moderate Adverse Events related to the TPAD were observed.
Overall, across this wide range of metrics, the use of TPAD for Veress needle insertion and insufflation was not significantly different than the use of the standard of care for Veress needle insertion and insufflation. These clinical performance data therefore support that the subject device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 § 884.9.
0
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October 15, 2024
TauTona Group Mike Blanchette Chief Operating Officer 604 Fifth Ave Suite D Redwood City, California 94063
Re: K242536
Trade/Device Name: TauTona Pneumoperitoneum Assist Device (TPAD) Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: August 21, 2024 Received: August 26, 2024
Dear Mike Blanchette:
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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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
2
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,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242536
Device Name
TauTona Pneumoperitoneum Assist Device (TPAD)
Indications for Use (Describe)
The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the Veress Needle for the establishment of a pneumoperitoneum during laparoscopic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K242536 Page 1 of 4
510(k) SUMMARY
SUBMITTER INFORMATION
| Applicant: | TauTona Research and Development Group, LLC | |
|---|---|---|
| Contact: | Mike Blanchette | |
| Phone: | 650-503-8250 | |
| Email: | mblanchette@tautonagroup.com | |
| Address: | 604 Fifth Ave, Suite D | |
| Redwood City, CA 94063 |
CORRESPONDENT INFORMATION
| Contact: | Joshua Crist |
|---|---|
| Title: | Regulatory Consultant- Medical Device |
| Firm: | Biologics Consulting Group |
DATE PREPARED: 10/10/24
DEVICE INFORMATION
| Device Name: | TauTona Pneumoperitoneum Assist Device (TPAD) |
|---|---|
| Common Name: | TPAD |
| Regulation Number: | 884.1730 |
| Regulation Name: | Laparoscopic insufflator |
| Product Code: | HIF |
| Regulatory Class: | Class II |
PREDICATE DEVICE INFORMATION
| Device Name: | TauTona Pneumoperitoneum Assist Device
(TPAD) |
|----------------|--------------------------------------------------|
| 510(k) Number: | K233020 |
| Manufacturer: | TauTona Research and Development Group, LLC |
The predicate device has not been subject to a design related recall.
5
510(k) SUMMARY
DEVICE DESCRIPTION
The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.
INDICATIONS FOR USE
The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with a Veress needle for the establishment of a pneumoperitoneum during laparoscopic procedures.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The table below compares the intended use and the technological characteristics of the subject device and predicate device.
| | Subject Device
TauTona
Pneumoperitoneum Assist
Device (TPAD) | Predicate Device
TauTona
Pneumoperitoneum Assist
Device (TPAD)
K233020 | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HIF | HIF | Same |
| Regulation Number | 884.1730 | 884.1730 | Same |
| Regulatory Class | II | II | Same |
| Indications for Use | The TauTona
Pneumoperitoneum Assist
Device (TPAD) is intended
for use with a Veress
needle for the establishment
of a pneumoperitoneum
during laparoscopic
procedures. | The TauTona
Pneumoperitoneum Assist
Device TPAD is intended for
use in the upper left quadrant of
the abdominal wall (i.e.,
Palmer's Point) with a Veress
needle for the establishment of a
pneumoperitoneum during
laparoscopic procedures. | Similar indications
for use. Predicate
TPAD location for
use is for Palmer's
Point Access. This
510k is to expand
to all regions of the
abdominal wall,
including Palmer's
Point and
umbilical regions. |
| Veress Needle Insertion | Use of negative pressure to
attach to skin to support Veress
needle insertion. Device can be | Use of negative pressure to
attach to skin to support Veress
needle insertion. Device can be
removed while Veress Needle
is in place. | Same |
Comparator Table for Subject and Predicate Devices Table 1:
6
K242536 Page 3 of 4
| | Subject Device
TauTona
Pneumoperitoneum Assist
Device (TPAD) | Predicate Device
TauTona
Pneumoperitoneum Assist
Device (TPAD) K233020 | Comparison |
|----------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|------------|
| | removed while Veress Needle
is in place. | | |
| Vacuum Application | Array of suction cups | Array of suction cups | Same |
| Vacuum Source | External – Hospital Vacuum
Line | External – Hospital Vacuum
Line | Same |
| Software/Electronics | None | None | Same |
| Biocompatible | Biocompatibility testing in
accordance with ISO 10993-1 | Biocompatibility testing in
accordance with ISO 10993-1 | Same |
510(k) SUMMARY
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Biocompatibility Testing
Studies were performed and confirmed that the Subject device is biocompatible for the intended patient contact profile in accordance with ISO 10993-1.
Electrical Safety
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Electromagnetic Compatibility (EMC)
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software
Not applicable. The subject device contains no software.
Performance Testing
Performance testing meets its design requirements and performs as intended. This testing is the same as the predicate device. The performance tests include:
- Dimensional testing for vacuum line compatibility, device features ●
- Vacuum control /holding forces. ●
- Tensile strength
7
K242536 Page 4 of 4
510(k) SUMMARY
Clinical Data
The clinical study was performed in two phases. The first phase included 20 patients and evaluated the TPAD vs. Standard of Care (SOC) for patients undergoing laparoscopic surgery where the Veress Needle was used to establish a pneumoperitoneum (see K233020). The majority of Veress entries were in the upper left quadrant (i.e. Palmer's point). The second phase of the study included 10 patients and focused on the umbilical region of the abdominal wall. In both phases the studies compared satisfaction, time, and skin impacts. The primary endpoint of the average surgeon questionnaire scoring was not significantly different for SOC and TPAD across all responses. The average timing measurements from the incision to Veress Needle Insertion, as well as time from incision to insufflation, were not significantly different between SOC and TPAD for both timing durations. The average patient questionnaire scoring was not significantly different for SOC and TPAD across all responses. No Severe or Moderate Adverse Events related to the TPAD were observed.
Overall, across this wide range of metrics, the use of TPAD for Veress needle insertion and insufflation was not significantly different than the use of the standard of care for Veress needle insertion and insufflation. These clinical performance data therefore support that the subject device is substantially equivalent to the predicate.
CONCLUSION
The subject device has the same technological characteristics and intended use as the predicate device, with a more general indications for use statement. Clinical testing conducted with the subject device demonstrates that it is as safe and effective as the predicate device to support a substantial equivalence determination.