(112 days)
Not Found
No
The device description and performance studies focus on mechanical manipulation and vacuum assistance, with no mention of AI/ML terms, image processing, or data training/testing related to AI/ML algorithms.
No
The device is intended to assist in the establishment of a pneumoperitoneum during laparoscopic procedures by manipulating tissue, not to treat or diagnose a disease or condition.
No
The device is described as an assist device for establishing pneumoperitoneum during laparoscopic procedures by manipulating tissue, not for diagnosing medical conditions.
No
The device description clearly outlines physical components including a pad with suction cups, a port for vacuum, a button, and a handle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- TPAD Function: The TauTona Pneumoperitoneum Assist Device (TPAD) is a surgical assist device. Its function is to physically manipulate tissue on the abdominal wall to aid in the insertion of a Veress needle during laparoscopic procedures. It does not analyze any biological specimens.
The description clearly states its purpose is to "manipulate (hold and pull on) the tissue around the Veress needle insertion site" and it is used "in the upper left quadrant of the abdominal wall". This is a physical manipulation of the body, not an in vitro test.
N/A
Intended Use / Indications for Use
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.
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
upper left quadrant of the abdominal wall (i.e., Palmer's Point)
Indicated Patient Age Range
individuals greater than 18 years old (age range 25 - 73 years old)
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
A randomized clinical study consisting of two arms was performed at an academic center in the U.S. The purpose of this study was to evaluate the safety, effectiveness and ease of use of the TPAD for laparoscopic surgery when the Veress Needle was used to establish pneumoperitoneum. Study population included 20 individuals greater than 18 years old (age range 25 - 73 years old), with a BMI
§ 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
Image /page/0/Picture/0 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" in blue, with the word "ADMINISTRATION" underneath.
January 12, 2024
TauTona Group Research & Development, Co. LLC Michael Blanchette Chief Operating Officer 604 Fifth Ave Suite D Redwood City, CA 94063
Re: K233020
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: December 8, 2023 Received: December 11, 2023
Dear Michael 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" (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 (OS) 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 QS 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 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,
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
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Indications for Use
510(k) Number (if known) K233020
Device Name
TauTona Pneumoperitoneum Assist Device (TPAD)
Indications for Use (Describe)
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.
| 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
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: 01/09/2024
DEVICE INFORMATION
| Device Name: | TauTona Pneumoperitoneum Assist Device (TPAD) |
|---|---|
| Common Name: | Laparoscopic insufflator |
| Regulation Number: | 884.1730 |
| Regulation Name: | Laparoscopic insufflator |
| Product Code: | HIF |
| Regulatory Class: | Class II |
PREDICATE DEVICE INFORMATION
| Device Name: | Aragon Surgical LapCap |
|---|---|
| 510(k) Number: | K070651 |
| Manufacturer: | Aragon Surgical Inc. |
The predicate device has not been subject to a design related recall.
4
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 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.
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
Aragon Surgical LAPCAP
K070651 | 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 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. | The Aragon Surgical LapCap is
intended for use in the peri-
umbilical region of the
abdominal wall with a Veress
needle for the establishment of
a pneumoperitoneum during
gynecologic (pelvic) and
general surgical
(intraabdominal) laparoscopic
procedures. | Similar indications
for use. TPAD
Location for use is
for Palmers Point
Access. |
| 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 is
removed with Veress Needle. | Same operating
principle.
Different removal
requirements. |
Table 1: Comparator Table for Subject and Predicate Devices
5
| | Subject Device
TauTona
Pneumoperitoneum Assist
Device (TPAD) | Predicate Device
Aragon Surgical LAPCAP
K070651 | Comparison |
|----------------------|-----------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | removed while Veress Needle
is in place. | | |
| Vacuum Application | Array of suction cups | Large polycarbonate dome | Similar, the minor
differences are
supported by both
bench and clinical
data. |
| Vacuum Source | External – Hospital Vacuum
Line | External – Hospital Vacuum
Line | Same |
| Software/Electronics | None | None | Same |
| Biocompatibility | Biocompatibility testing in
accordance with ISO 10993-1 | Biocompatibility testing in
accordance with ISO 10993-1 | Same |
510(K) SUMMARY
Both devices use negative pressure to attach to skin and support Veress Needle insertion. The subject device, however, applies the vacuum with a design that allows removal of the device after Veress Needle insertion.
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
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- Dimensional testing for vacuum line compatibility, device features
- Vacuum control /holding forces. ●
6
- . Tensile strength
- Shelf-Life .
Clinical Data
A randomized clinical study consisting of two arms was performed at an academic center in the U.S. The purpose of this study was to evaluate the safety, effectiveness and ease of use of the TPAD for laparoscopic surgery when the Veress Needle was used to establish pneumoperitoneum. Study population included 20 individuals greater than 18 years old (age range 25 - 73 years old), with a BMI