(86 days)
The PIPELINE Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
The PIPELINE II Access System consists of a series of dilators and tubular retractors with integrated light source of various lengths and diameters to provide access to the spine for minimally invasive procedures. The PIPELINE II Access System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the PIPELINE II Access System, a self-retaining retractor for neurosurgery. However, it does not contain the kind of performance data, acceptance criteria, or study details typically associated with AI/ML devices or diagnostic tools that would have such reported metrics.
The document is a 510(k) summary for a physical surgical device, and its "Performance Data" section simply states: "Performance data were submitted to characterize the PIPELINE II Access System components." This indicates that the performance data refers to the physical properties and functionality of the surgical components themselves (e.g., material strength, dimensions, sterilizability), not to accuracy, sensitivity, or specificity metrics like those found in AI/ML or diagnostic device studies.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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- X. 510(k) Summarv KO62814 SUBMITTER: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780 DEC 1 5 2006 CONTACT PERSON: Daphney Germain DATE PREPARED: September 18, 2006 CLASSIFICATION NAME: Retractor, Self-Retaining, For Neurosurgery 8882.4800 PROPRIETARY NAME: PIPELINE II Access System PREDICATE DEVICE: Bright Medical Dilation Retractor System, K992898 DEVICE DESCRIPTION: The PIPELINE II Access System consists of a series of dilators and tubular retractors with integrated light source of various lengths and diameters to provide access to the spine for minimally invasive procedures. The PIPELINE II Access System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. The PIPELINE Access System is intended to provide the INTENDED USE: surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated. MATERIALS: Manufactured from ASTM 17-4 PH Stainless Steel, Bariumfilled Radel or Polyetheretherketone (PEEK), epoxy, and glass fiber optics. PERFORMANCE DATA: Performance data were submitted to characterize the PIPELINE II Access System components.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine % Ms. Sharon Starowicz Director, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767-0350
DEC 1 5 2006
Re: K062814
Trade/Device Name: PIPELINE II Access System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: November 15, 2006 Received: November 16, 2006
Dear Ms. Starowicz:
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 practicc 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.
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Page 2 - Ms. Sharon Starowicz
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Indications for Use
510(k) Number (if known):
Device Name: PIPELINE II Access System
Indications For Use:
The PIPELINE Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the lamina, with its attachment to a rigid arm to provide a self-locking method of access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Prescription Use:
OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkum
(Division Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K062814
DePuy Spine, Inc. Special 510K
Page 8
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).