(74 days)
No
The summary describes a system of manual surgical instruments and retractors for minimally invasive spinal access, with no mention of AI or ML capabilities, image processing, or data-driven components.
No
Explanation: The device is intended to provide surgical access and facilitate manipulation of surgical instruments. It does not exert any direct therapeutic effect on the patient.
No
The device description and intended use clearly state that the system is for providing surgical access and facilitating instrument manipulation, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like dilators, tubular retractors, and manual surgical instruments, indicating it is a hardware-based 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 describes a surgical access system used during surgery to provide a pathway to the spine for visualization and instrument manipulation. This is a surgical tool, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details dilators, retractors, and manual surgical instruments. These are all physical tools used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the SPOTLIGHTTM Access System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The SPOTLIGHTTM 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 posterior and posterolateral bony spinal elements. These ports 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
Device Description
The SPOTLIGHT™ Access System consists of a series of dilators and tubular retractors with and without integrated light source of various lengths and diameters designed to provide minimally invasive surgical access to the spine. The SPOTLIGHT™ Access System also contains Class I manual 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
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)
Compressive Force Testing: Met the same specification as the predicate device. Outcome: Pass.
Static Torque Testing on Fixed Handle Connection: All samples met the acceptance criteria. Outcome: Pass.
Validation of Reprocessing Instructions: An evaluation of the devices for equivalency to previously validated devices for reprocessing cleaning and sterilization was performed and documented according to DePuy Spine, Inc. internal procedures. Outcome: Pass.
USP Physiochemical Test for Plastics: Non-volatile Residue- Conforms; Residue on Ignition- Conforms; Heavy Metals- Conforms; Buffering Capacity- Conforms. Outcome: Conforms- passes all acceptance criteria.
In vitro Cytotoxicity Agar Diffusion: Cell culture treated with test sample exhibited Slight (Grade I) Reactivity. Outcome: Non-cytotoxic.
In vitro Cytotoxicity MEM Elution Test: Cell culture treated with sample extract exhibited no cells lysis (Grade 0 Reactivity). Outcome: Non-cytotoxic.
Sensitization Test - Guinea Pig Maximization: No significant difference in biological response between test article and negative control. Outcome: Non- sensitizing.
Irritation/Intracutaneous Reactivity USP Intracutaneous Test: The difference between the mean scores for the sample extracts and corresponding blanks was 0.5 or less. Outcome: Non-irritating.
Acute Systemic Toxicity USP Systemic Injection Test: None of the animals treated with the sample extracts showed any signs of toxicity and all gained weight. Outcome: Non-toxic.
In vitro Genotoxicity - Ames Bacterial Mutagenicity Assay: None of the five tester strains produced two-fold increases in the number of revertants. The spot tests showed no zone of increased reversion or of inhibition. Outcome: Non-mutagenic.
Implantation USP Implantation Test: No encapsulation was observed grossly in any of the test or control sites, and no irritation was observed microscopically at the test sites compared to the control sites. Outcome: The test material met the requirements of the USP Implantation Test when implanted for seven days.
In vitro Hemolysis Extraction Method: Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic. Outcome: Non-hemolytic.
In vitro Hemolysis Direct Contact: Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic. Outcome: Non-hemolytic.
Material-Mediated Pyrogenicity USP Rabbit Pyrogen Test: No rabbit showed an individual rise in temperature of 0.5°C or more. Outcome: Non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
KIT2913
510(K) SUMMARY
DEC 1 6 2011
Submitter Information A.
DePuy Spine, Inc. . 325 Paramount Drive Raynham, MA 02767
Contact Person: Address:
Telephone number:
Fax number:
Laura Bleyendaal 325 Paramount Drive Raynham, MA 02767 (508) 828-3267 (508) 828-3797 LBleyend@its.jnj.com
December 8, 2011
Date Prepared B.
Email:
C. Device Name
SPOTLIGHTTM Access System Trade/Proprietary Name: Self-retaining retractor for neurosurgery Common/Usual Name: Retractor, Self-Retaining, For Neurosurgery Classification Name: per 21 CFR § 882.4800
Predicate Device Name D.
DePuy Spine, Inc. SPOTLIGHT™ Access System (K062814) Trade name: Bright Medical Dilation Retractor System (K992898)
Device Description E.
The SPOTLIGHT™ Access System consists of a series of dilators and tubular retractors with and without integrated light source of various lengths and diameters designed to provide minimally invasive surgical access to the spine. The SPOTLIGHT™ Access System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
DePuy Spine, Inc., a Johnson & Johnson Company
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Intended Use F.
The SPOTLIGHT™ 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 posterior and posterolateral bony spinal elements. These ports 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 F.
- The wall thickness of the proposed ports varies from the i. proximal to the distal end. The wall thickness of the proposed ports is less than that of the previously cleared SPOTLIGHT™ Access System ports and greater than that of the previously cleared Bright Medical Dilation Retractor System ports.
- The proposed ports have a permanently fixed handle at the ii. proximal end for manual manipulation.
- Like the previously cleared Bright Medical Dilation iii. Retractor System ports, the proposed ports do not contain an integrated light source.
- The proposed port lengths and outer diameters are iv. consistent with previously cleared SPOTLIGHT™ Access System port offerings.
- The proposed ports are manufactured from a different v. material (anodized 6061 T6 aluminum) than the previously cleared SPOTLIGHT™ Access System ports and Bright Medical Dilation Retractor System ports.
Materials G.
The subject ports are manufactured from anodized 6061 T6 aluminum. The material conforms to the following ASTM standards: B211 and B221.
2
H. Performance Data
| Test System | Study Results | Conclusion |
|---|---|---|
| Compressive Force | ||
| Testing | Met the same specification as the | |
| predicate device | Pass | |
| Static Torque Testing | ||
| on Fixed Handle | ||
| Connection | All samples met the acceptance | |
| criteria | Pass | |
| Validation of | ||
| Reprocessing | ||
| Instructions | An evaluation of the devices for | |
| equivalency to previously validated | ||
| devices for reprocessing cleaning | ||
| and sterilization was performed and | ||
| documented according to DePuy | ||
| Spine, Inc. internal procedures. | Pass | |
| USP Physiochemical | ||
| Test for Plastics | Non-volatile Residue- Conforms | |
| Residue on Ignition- Conforms | ||
| Heavy Metals- Conforms | ||
| Buffering Capacity- Conforms | Conforms- passes | |
| all acceptance | ||
| criteria | ||
| In vitro Cytotoxicity | ||
| Agar Diffusion | Cell culture treated with test | |
| sample exhibited Slight (Grade I) | ||
| Reactivity | Non-cytotoxic | |
| In vitro Cytotoxicity | ||
| MEM Elution Test | Cell culture treated with sample | |
| extract exhibited no cells lysis | ||
| (Grade 0 Reactivity) | Non-cytotoxic | |
| Sensitization Test - | ||
| Guinea Pig | ||
| Maximization | No significant difference in | |
| biological response between test | ||
| article and negative control. | Non- sensitizing | |
| Irritation/Intracutaneous | ||
| Reactivity | ||
| USP Intracutaneous | ||
| Test | The difference between the mean | |
| scores for the sample extracts and | ||
| corresponding blanks was 0.5 or | ||
| less. | Non-irritating | |
| Acute Systemic | ||
| Toxicity | ||
| USP Systemic Injection | ||
| Test | None of the animals treated with | |
| the sample extracts showed any | ||
| signs of toxicity and all gained | ||
| weight. | Non-toxic | |
| In vitro Genotoxicity - | ||
| Ames Bacterial | ||
| Mutagenicity Assay | None of the five tester strains | |
| produced two-fold increases in the | ||
| number of revertants. The spot | ||
| tests showed no zone of increased | ||
| reversion or of inhibition. | Non-mutagenic | |
| Implantation | ||
| USP Implantation Test | No encapsulation was observed | |
| grossly in any of the test or control | ||
| sites, and no irritation was | ||
| observed microscopically at the test | ||
| sites compared to the control sites. | The test material | |
| met the | ||
| requirements of | ||
| the USP | ||
| Implantation Test | ||
| when implanted | ||
| for seven days | ||
| In vitro Hemolysis | ||
| Extraction Method | Less than 5% hemolysis- A test | |
| sample with 5% or less hemolysis | ||
| is considered non-hemolytic. | Non-hemolytic | |
| In vitro Hemolysis | ||
| Direct Contact | Less than 5% hemolysis- A test | |
| sample with 5% or less hemolysis | ||
| is considered non-hemolytic. | Non-hemolytic | |
| Material-Mediated | ||
| Pyrogenicity | ||
| USP Rabbit Pyrogen | ||
| Test | No rabbit showed an individual rise | |
| in temperature of 0.5°C or more. | Non-pyrogenic |
DePuy Spine, Inc., a Johnson & Johnson Company
Page 3
.
.
3
I. Conclusion
Both the performance testing and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2011
Johnson & Johnson c/o Ms. Laura Bleyendaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K112913
Trade/Device Name: SPOTLIGHT™ Access System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: Class II Product Code: GZT Dated: December 1, 2011 Received: December 2, 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.
5
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 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,
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
6
INDICATIONS FOR USE STATEMENT
510(k) Number: K112913
Device Name: SPOTLIGHTTM Access System
Indications For Use:
The SPOTLIGHTTM 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 posterior and posterolateral bony spinal elements. These ports 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__