(62 days)
Not Found
Not Found
No
The device description and intended use clearly describe manual surgical instruments (trocar and sleeve) used for creating access points in endoscopic surgery. There is no mention of any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a manual surgical instrument used for incision and peritoneal access during endoscopic surgery, not for treating or preventing disease.
No
The device description clearly states it is a "manual surgical instrument" used for incision and access during endoscopic surgery, allowing for the passage of other instruments or probes. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly details physical components (Trocar, Sleeves, Caps) made of polymers and stainless steel, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a manual surgical instrument used for creating access points during endoscopic surgery. It facilitates the insertion of other surgical instruments, laparoscopes, and probes into the body.
- Device Description: The description details the physical components (trocar, sleeve, cap) and their function in providing a sealed port of entry into the peritoneal cavity.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens obtained from the body (like blood, tissue, or other bodily fluids) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these types of tests performed in vitro (outside the body).
This device is a surgical instrument used in vivo (within the body) to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.
The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.
Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.
The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Pilling Weck Trocar and Sleeve is substantially equivalent to the Core Dynamics Entree II. Apple Medical Hunt Reich Secondary Trocar, and the Access Surgical Access Single Use Trocar and Sleeve.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Pilling Weck. The logo consists of a stylized "W" symbol on the left, followed by the text "Pilling Weck" in a bold, sans-serif font. The "W" symbol is composed of three interconnected, angular shapes, with a small diamond shape positioned above the center of the "W".
510(k) Summarv
June 11, 1997
1. Submitter Name, Address, and Date of Submission:
Miss Karenann J. Brozowski Group Regulatory Affairs Director Pilling Weck Group Tall Pines Park Jaffrev. NH 03452
Telephone: (603)532-7706
Contact: Same as above.
2. Names of the Device, Common, Proprietary(if Known), and Classification.
Classification Name: Secondary Trocar with Sleeve
Common Name: Secondary Trocar with Sleeve
Proprietary Name: Pilling Weck Secondary Flexible Sleeve and Trocar
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Pilling Weck Trocar and Sleeve is substantially equivalent to the Core Dynamics Entree II. Apple Medical Hunt Reich Secondary Trocar, and the Access Surgical Access Single Use Trocar and Sleeve.
4. Description of the Device:
The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.
A Telefiex Company One Weck Drive, P.O. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000
1
The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
5. Intended Use of the Device:
The Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.
Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
The usage of this product is identical to previous devices, which have the same technological characteristics.
6. Summary of Technological Characteristics:
The following technological characteristics are the same or equivalent as predicate devices:
The Trocar, consisting of a polymer shaft and hub with stainless steel tip, is equivalent to the predicates.
The sleeve used with the Trocar is treaded, which is equivalent to the predicates.
The Cap Assembly contains the seal, which is used to minimize the leakage from the pneumoperitoneum, which is equivalent to the predicates.
summm/o
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a bird or a human figure in profile, with flowing lines suggesting movement or support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1997
Ms. Karenann J. Brozowski Group Regulatory Affairs Director Pilling Weck Group · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · Tall Pines Park Jaffrey, New Hamphsire 03452
《大 Re:
K971334 Trade Name: Pilling Weck Secondary Flexible Sleeve with Trocar Regulatory Class: II Product Code: GCJ Dated: April 4, 1997 Received: April 10, 1997
Dear Ms. Brozowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Karenann J. Brozowski
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): K9911334
Device Name: __ Pilling Weck Secondary Flexible Sleeve with Trocar
Indications for Use:
The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.
The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures The Trocar is used in Enkbecopic Surgery (offices by J. S.
and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.
Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971334 |
| Prescription Use |
|
|----------------------|--------------------|
| (Per 21 CFR 801.109) | |
OR
| Over-The-Counter Use |
|---|
| ---------------------- |
(Optional Format 1-2-96)