(81 days)
Not Found
No
The summary describes a mechanical retractor system and its accessories, with no mention of AI or ML capabilities. The performance study focuses on thermal testing, not algorithmic performance.
No
This device is a surgical retractor and access system, which aids in providing a clear surgical field for surgeons, but it does not directly treat or diagnose a disease or condition; it is a tool for a therapeutic procedure.
No
Explanation: The device is described as a surgical access system and retractor intended to provide physical access to the spine for surgical procedures. It does not perform any diagnostic functions like analyzing data or detecting medical conditions.
No
The device description explicitly mentions hardware components such as a modular three blade expandable retractor, lighted and non-lighted blades, a fiber optic Y cable, surgical instruments, and cases.
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 for providing surgical access to the spine for minimally invasive procedures. This is a surgical tool used during a procedure on a patient.
- Device Description: The description details a surgical retractor and associated instruments. These are physical tools used to manipulate tissue and provide visualization during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The SPOTLIGHT™ Access System and SPOTLIGHT™ PL are intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Product codes
GZT, FSQ
Device Description
The SPOTLIGHT™ PL is a modular three blade expandable retractor, with the option of lighted and non lighted blades, which provides access to the spine for minimally invasive procedures. A fiber optic Y cable is included for use with the retractor.
The SPOTLIGHT™ PL also contains surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (posterior and posterolateral bony spinal elements)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
| Test System | Study Results | Conclusions |
|---|---|---|
| Thermal Testing | The maximum surface temperature in IEC 60601-2-18 for medical equipment applied parts was not exceeded | Pass |
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
§ 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).
0
JAN 2 7 2012
510(K) SUMMARY
= =
..............................................................................................................................................................................
Submitter Information A.
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
Contact Person: Address:
Telephone number: Fax number: Email:
Laura Bleyendaal 325 Paramount Drive Raynham, MA 02767 (508) 828-3267 (508) 828-3797 LBleyend@its.jnj.com
Date Prepared B.
January 23, 2012
SPOTLIGHT™ PL
- C. Device Name
Trade/Proprietary Name:
Common/Usual Name:
Retractor
Class II
Device Class:
FDA Product Code:
GZT- Retractor, self-retaining, for neurosurgery FSQ- Light, surgical, instrument
Regulation:
Self-retaining retractor for neurosurgery per 21 CFR § 882.4800 Surgical lamp per 21 CFR § 878.4580
Predicate Device Name D.
DePuy Spine, Inc. SPOTLIGHT™ Access System (K062814) Trade name: Medtronic, Inc. MAST QUADRANT™ Retractor System (K043602)
1
V. Mueller® Cardinal Health Versa-Trac® Lumbar Retractor System (K964402)
Device Description E.
The SPOTLIGHT™ PL is a modular three blade expandable retractor, with the option of lighted and non lighted blades, which provides access to the spine for minimally invasive procedures. A fiber optic Y cable is included for use with the retractor.
The SPOTLIGHT™ PL also contains surgical instruments and cases that are considered exempt from premarket notification.
F. Intended Use
The SPOTLIGHT™ Access System and SPOTLIGHT™ PL are intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Summary of Similarities and Differences in Technological Characteristics G.
- i. The proposed retractor features modular reusable blades like the predicate MAST QUADRANT™ and Versa-Trac® retractors. The proposed blade lengths are consistent with the predicate Versa-Trac® Lumbar Retractor System blade offerings.
- The proposed retractor may be connected to a rigid arm similar to ii. the predicate MAST QUADRANT™ retractor and SPOTLIGHTTM Access System ports.
- The proposed retractor includes an integrated light source like the iii. predicate SPOTLIGHTTM Access System ports. Specifically, lateral blades with integrated fiber optics are available for use with the proposed retractor. Non lighted lateral blades are available as well. A fiber optic Y cable is included to connect the two lateral blades with integrated fiber optics to a light cable.
2
- The proposed retractor may also accommodate a third party light iv. source on the middle blade similar to the MAST QUADRANT™ retractor.
H. Materials
The components of the proposed retractor are manufactured from stainless steel (for the retractor handle and blades) and proprietary fiber optics in a bonding material (for the lighted blades). The Y cable is manufactured from stainless steel, rigid plastic, flexible rubber, and proprietary fiber optics.
Performance Data I.
| Test System | Study Results | Conclusions |
|---|---|---|
| Thermal Testing | The maximum | |
| surface temperature | ||
| in IEC 60601-2-18 | ||
| for medical | ||
| equipment applied | ||
| parts was not | ||
| exceeded | Pass |
J. Conclusion
The substantial equivalence justification and thermal testing data demonstrate that the device is as safe and as effective as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. c/o Ms. Laura Bleyendaal Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767
JAN 2 7 2012
Re: K113273
Trade/Device Name: SPOTLIGHTTM PL Regulation Number: 21 CFR 882.4800 Regulation Name: Self-Retaining Retractor for Neurosurgery Regulatory Class: Class II Product Code: GZT and FSQ Dated: November 4, 2011 Received: November 7, 2011
Dear Ms. Bleyendaal:
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 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.
4
Page 2 - Ms. Laura Bleyendaal
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 (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.
If 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/ucm115809.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.fda.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Valentin mt
Major R. E. de la V. R.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
K113273 510(k) Number (if known):
Device Name: SPOTLIGHT™ PL
Indications For Use:
The SPOTLIGHT™ Access System and SPOTLIGHT™ PL are intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port or retractor, down to the posterior and posterolateral bony spinal elements. These ports and retractors provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
JEFFREY Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113273