(90 days)
Not Found
No
The description focuses on the mechanical function of a surgical seal and does not mention any computational or analytical capabilities.
No.
The device acts as a port of entry and maintains pneumoperitoneum during surgical procedures, which are supportive functions rather than direct therapeutic actions to treat a disease or condition.
No
The device description states it is a sterile, single-use device used as a port of entry for surgical instruments during minimally invasive procedures and maintains pneumoperitoneum. Its function is to facilitate surgical access and maintain internal pressure, not to diagnose medical conditions through data collection or analysis.
No
The device description clearly indicates it is a physical, sterile, single-use device made from materials used in currently marketed medical devices, intended for use as a port of entry during surgical procedures. It is a hardware component of a trocar assembly.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as a port of entry for surgical instruments during minimally invasive procedures. This is a surgical device, not a diagnostic one.
- Device Description: The description focuses on its function in maintaining pneumoperitoneum and sealing around surgical instruments. This is a mechanical function within the body, not a test performed on a sample outside the body.
- No mention of diagnostic testing: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Applied Access Seal is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products for use as a port of entry for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
Product codes
GCJ
Device Description
A standard trocar assembly consists of an obturator, a seal and a cannula system. The Applied Access Seal is designed for use with Applied Medical's Cannulas and Obturators. An Applied Medical Trocar will consist of the Applied Access Seal, a cannula and an obturator.
The Applied Access Seal when used in laparoscopic surgery is designed to maintain pneumoperitoneum or positive pressure at its distal end to prevent loss of surgical gas. The device is designed to seal around surgical instruments, which are typically inserted through the device during surgery, to prevent loss of pneumoperitoneum during use and exchange of such instruments. The Applied Access seal is available with a stop-cock through which carbon dioxide or other gas may be dispensed into the surgical site during laparoscopic surgery.
The Applied Access Seal is made from materials used in currently marketed medical devices and has passed biocompatibility testing required per ISO 10993-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general, abdominal, gynecological and thoracic
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
The performance and functional testing of the Applied Access Seal included tests to verify integrity of seal and leakage through the seal. The performance and functional testing demonstrated that the Applied Access Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
Key Metrics
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
| DEC 0 3 2001 | 510(k) SUMMARY |
|---|---|
| 510(k) NUMBER: | PENDING |
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 22872 Avenida Empresa | |
| Rancho Santa Margarita, CA-92688 | |
| (949) 713-8000 | |
| CONTACT PERSON: | Anil Bhalani |
| Vice President of Regulatory Affairs and Clinical Programs | |
| DATE OF PREPARATION: | August 31, 2001 |
| NAME OF DEVICE: | Trocar Seal |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
| TRADE NAME: | Applied Access Seal |
| PREDICATE DEVICE: | Premium Disposable Seal, Applied Medical Resources |
| (K932995) |
INTENDED USE: The Applied Access Seal is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products for use as a port of entry for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
DEVICE DESCRIPTION: A standard trocar assembly consists of an obturator, a seal and a cannula system. The Applied Access Seal is designed for use with Applied Medical's Cannulas and Obturators. An Applied Medical Trocar will consist of the Applied Access Seal, a cannula and an obturator.
The Applied Access Seal when used in laparoscopic surgery is designed to maintain pneumoperitoneum or positive pressure at its distal end to prevent loss of surgical gas. The device is designed to seal around surgical instruments, which are typically inserted through the device during surgery, to prevent loss of pneumoperitoneum during use and exchange of such instruments. The Applied Access seal is available with a stop-cock through which carbon dioxide or other gas may be dispensed into the surgical site during laparoscopic surgery.
The Applied Access Seal is made from materials used in currently marketed medical devices and has passed biocompatibility testing required per ISO 10993-1.
1
PERFORMANCE DATA SUMMARY: The performance and functional testing of the Applied Access Seal included tests to verify integrity of seal and leakage through the seal. The performance and functional testing demonstrated that the Applied Access Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K012968
Trade/Device Name: Applied Access Seal Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 31, 2001 Received: September 4, 2001
Dear Mr. Bhalani:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Mr. Anil Bhalani
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to cogen finding of substantial equivalence of your device to a legally promatics notification. The Pro Linessification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Fart 007.10 for questions on the promotion and advertising of Comphance ut (301) 594-1697 ffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outer general miormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker
fa
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied Access Seal "Indications for Use" as required.
Not assigned K012968 510(k) Number:
Applied Access Seal Device Name:
Indications for Use: The Applied Access Seal is a sterile single use device, indicated for use in conjunction with Applied's currently marketed Trocar products where a port of entry is desired for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | -------------- |
OR Over-The-Counter Use__________ (Optional Format 1-2-96)
Susan Wall
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number: K012968