(40 days)
Not Found
No
The summary describes a mechanical surgical port and does not mention any AI/ML terms or functionalities.
No
The device is described as providing a pathway for surgical instruments, not directly treating a medical condition.
No
Explanation: The device is described as providing a pathway for the introduction of endoscopic surgical devices and maintaining insufflation, not for diagnosing conditions.
No
The device description clearly describes a physical medical device (a port) used in surgical procedures, not a software-only application.
Based on the provided information, the ADAPt™ Universal Balloon Open Access Port is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ADAPt™ Universal Balloon Open Access Port is a surgical instrument used to create a pathway for other surgical devices during minimally invasive procedures. It is used in vivo (within the body) to facilitate surgery, not to analyze samples in vitro (outside the body).
- Intended Use: The intended use clearly states it's for providing a pathway for the introduction of endoscopic surgical devices during procedures. This is a surgical function, not a diagnostic one.
Therefore, the ADAPt™ Universal Balloon Open Access Port falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADAPt™ Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Product codes
GCJ
Device Description
ADAPt™ Universal Balloon Open Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. ADAPTM Universal Balloon Open Access Port is intended to be used by trained physicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, abdominal, and gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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 bench testing has been performed to verify that the performance of the proposed ADAPt™ Universal Balloon Open Access Port is substantially equivalent to the predicate device, and that the ADAPITM Universal Balloon Open Access Port will perform as intended.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
ADAPT™ Universal Balloon Open Access Port
Section 8 - Summary of Safety and Effectiveness
Page 1.83
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ADAPT™ Universal Balloon Open Access Port
OCT - 4 2011
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8049 Fax: 919-433-4996
B. Contact Person
Special 510(k)
Natalie Smith Regulatory Affairs Specialist
C. Date Prepared
August 23, 2011
D. Device Name
Trade Name: ADAPt™ Universal Balloon Open Access Port
Common Name: Surgical Trocar
Classification Name: Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ)
E. Device Description
ADAPt™ Universal Balloon Open Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. ADAPTM Universal Balloon Open Access Port is intended to be used by trained physicians.
F. Indications for Use
The Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Teleflex Medical, Inc.
1
ADAPt™ Universal Balloon Open Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness
G. Contraindications
Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed.
H. Substantial Equivalence
The proposed Universal Balloon Open Access Port is substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| ADAPT™ Balloon Open Access | |||
| Port Model 41244 | Teleflex Medical, Inc. / | ||
| Taut, Inc. | K023261 | 12/13/02 | |
| ADAPT™ Universal | |||
| Laparoscopic Port | Teleflex Medical, Inc. / | ||
| Taut, Inc. | K082156 | 09/10/2008 |
I. Comparison To Predicate Devices
The essence of this change is the selection of previously approved key features from K023261; ADAPt™ Balloon Open Access Port Model 41244 and K082156; ADAPr™ Universal Laparoscopic Port, to produce a new consolidated design. No new Indications for Use, patient contacting materials, manufacturing processes, or risks have been introduced with these proposed modifications.
The new consolidated design of the ADAPt™ Universal Balloon Open Access features the Balloon from K023261 with the additional features of the Universal and Duckbill Seals arising from K082156. A polypropylene Ring Clamp (non-patient contacting) has replaced an acrylic cannula clamp (aka H clamp) from the previous design and the definition of the cannula working length has been clarified. In doing so, the actual working length of the Access Port has been lengthened to 125mm which is a length previously cleared for port access under K023261. All other proven attributes of the ADAPtTM Balloon Open Access Port remain the same.
J. Materials
All patient contacting materials are in compliance with ISO 10993-1.
K. Technological Characteristics
A comparison of the technological characteristics of the proposed ADAPITM Universal Balloon Open Access Port and the predicate has been performed. The results of this comparison demonstrate that the ADAPI™ Universal Balloon Open
2
ADAPt™ Universal Balloon Open Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness
Access Port is equivalent to the marketed predicate devices in performance characteristics.
L. Performance Data
The bench testing has been performed to verify that the performance of the proposed ADAPt™ Universal Balloon Open Access Port is substantially equivalent to the predicate device, and that the ADAPITM Universal Balloon Open Access Port will perform as intended.
L. Conclusion
Based upon the comparative test results, the proposed ADAPT™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K023261 and K082156. The modifications made to the proposed ADAPT™ Universal Balloon Open Access Port do not introduce any new issues of safety and effectiveness.
3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Teleflex Medical, Inc. % Ms. Natalie Smith Regulatory Affairs Specialist 2917 Week Drive Research Triangle Park. North Carolina 27709
OCT - 4 2011
Re: K112456
Trade/Device Name: Universal Balloon Open Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class H Product Code: GCJ Dated: September 13, 2011 Received: September 23, 2011
Dear Ms. Smith:
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 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 contraction and warranties. We remind you; however, that device labeling must be truthful and not misleading.
ff 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 not the Act
4
Page 2 - Ms. Natalie Smith
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm1 | 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K11 2456
Indications for Use
Page 1 of 1
510(k) Number:
Device Name:
Universal Balloon Open Access Port
Indications for Use:
The ADAPt™ Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use ・ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel R. Jale Eur nxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112456