(257 days)
The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue.
The OTELO®LL Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The OTELO®LL Retractor System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.
I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) summary for a medical device called the OTELO LL Retractor, which is a manual surgical instrument. The content focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical verification and validation test results for aspects like biocompatibility, cleaning, sterilization, and mechanical performance.
However, the provided text does not contain information about:
- Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC)
- Sample sizes for test sets (as it's not a diagnostic study)
- Data provenance, number of experts, adjudication methods, or ground truth for diagnostic accuracy studies
- Multi-reader multi-case (MRMC) comparative effectiveness studies with human readers
- Standalone (algorithm only) performance
- Training set details
The "acceptance criteria" discussed in the document are related to engineering and biological performance (e.g., no cytotoxic potential, no breakage of blades, successful cleaning and sterilization) rather than diagnostic performance against clinical ground truth.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Spineart Mr. Franck Pennesi International Center Cointrin 20 Route de Pre-bois - CP 1813 1215 GENEVA 15 Switzerland
Re: K151104
Trade/Device Name: OTELO LL Regulation Number: 21 CFR 878.4800 Regulation Name: Retractor Regulatory Class: Class I Product Code: GAD Dated: December 2, 2015 Received: December 4, 2015
Dear Mr. Pennesi:
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.
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
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
William J. Heetderks -S
for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151104
Device Name OTELO LL Retractor
Indications for Use (Describe)
The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | New devices |
| Submitted by | SPINEARTInternational Center Cointrin20 route de pré-boisCP18131215 GENEVA 15SWITZERLAND |
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 570 1246 Fax : +41 22 799 4026Mail : fpennesi@spineart.comRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr |
| Date Prepared | January 5, 2016 |
| Common Name | Retractor |
| Trade Name | OTELO® LL |
| Classification Name | Retractor |
| Regulation description | Manual surgical instrument for general use. |
| Class | I |
| Product Code | GAD |
| CFR section | 878.4800 |
| Device panel | General & Plastic Surgery |
| Legally marketed predicate devices | Primary predicate: Quadrant Retractor System (K043602) manufactured byMedtronic Sofamor Danek |
| Design features | OTELO LL retractor by SPINEART | MAST QUADRANT Retractor systemby Medtronic |
|---|---|---|
| 510(k) # | Present submission | K043602 |
| Product code | GAD | GAD |
| Pictures | Image: OTELO LL retractor | Image: MAST QUADRANT Retractor system |
| 21 CFR | 878.4800 | 878.4800 |
| Common name | Retractor, Manuel Surgical Instrument | Retractor, Manuel Surgical Instrument |
| Design features | OTELO LL retractor by SPINEART | MAST QUADRANT Retractor systemby Medtronic |
| Indications for use | The OTELO®LL Retractor is intended to providethe surgeon access to the spine by dissectionand traction of soft and bony tissue. | The MAST QUADRANT™ Retractor System isintended to provide surgeons withinstruments such as dilators, retractors,light sources and pedicle access needlesused to perform a variety of spinal fixationprocedures utilizing a minimally invasiveapproach. The MAST QUADRANT™Retractor System is indicated forvisualization of the surgical field in any areaof the body cut open during a surgicalprocedure. When used in the cervical,thoracic, or lumbar spine either from ananterior or posterior direction, for example,the MAST QUADRANT™ Retractors andaccessories are intended to aid thesurgeon's visualization of the surgical areaand allow him/her to perform any type ofsurgical spinal procedure such as herniateddisc repair, visualization of thecircumferential decompression of the nerveroots, aiding in the search and removal ofnucleus material, spinal fusion, or insertionof spinal implants. |
| Description | The OTELO®LL Retractor System is a tubular-based retraction system, designed to providesurgeons with the freedom to retract tissuethrough any combination of distracting orarticulating the blades. The OTELO®LLRetractor System includes instruments used toaccess the spine by dilating the overlyingtissues, as well serving as a retracting device tomaintain the access. The system can be used inconjunction with microscopes, light sources,cameras, or other visualization aids. | The MAST QUADRANT™ Retractor System isa tubular-based retraction system, designedto provide surgeons with the freedom toretract tissue through any combination ofdistracting or articulating the blades. TheMAST QUADRANT™ System includesinstruments used to access the spine bydilating the overlying tissues, as well servingas a retracting device to maintain theaccess. The system can be used inconjunction with microscopes, light sources,cameras, or other visualization aids. |
| Material | Stainless Steel, PEEK and PEEK Carbon. | Stainless Steel |
| Design features | Self-locking mechanism and minimal invasiveuse | Self-locking mechanism and minimalinvasive use |
| Operatingprinciple | Gives surgeons an easy access and goodvisualization of the disc to be treated. | Gives surgeons an easy access and goodvisualization of the disc to be treated. |
| Technologicalcharacteristics | The retractor system is composed of oneretractor base associated to differentinstruments such as dilators tube, blades,wires, retractor, shim pins, light source andflex arm attachment. Range of blades iscomposed of 10 right, 10 left and 10 posteriorblades which varies from 90 to 180 mm length.If needed, a fourth blade distraction systemcan be adapted in order to increase surgeon'saccess visibility. This complementary system iscomposed of 2 wide and 2 narrowsupplemental blades which varies from 5 to 10mm width. | The retractor system is composed of oneretractor base associated to differentinstruments such as dilators tube, blades,wires, retractor, light source and flex armattachment. Range of blades is composed of5 right and 5 left blades which varies from40 to 80 mm length. If needed, acomplementary medial /lateral distractionsystem can be adapted in order to increasesurgeon's access visibility. Thiscomplementary system is composed of 3wide and 3 narrow supplemental bladeswhich varies from 50 to 90 mm length |
| Design features | OTELO LL retractor by SPINEART | MAST QUADRANT Retractor systemby Medtronic |
| Ranges of theretractor openingdistance | Antero-posterior opening range: 21 mm to 46mmCranial-caudal opening range: 21 mm to 100mm | Cranial-caudal opening range: 30 mm to 52mm |
| Ranges of bladeangle | Cranial-Caudal inclination angle range:0° to +15° | / |
| Packaging | Instruments are individually packaged inpolyethylene sealed pouch with label and IFUincluded.When packaged as an Instrument set, the setis packaged in polyethylene sealed pouch withlabel and IFU included. | Same for non sterile instruments. |
| Shelf life | Not applicable. Devices are provided nonsterile. | / |
| Sterilization | Steam sterilization | Steam sterilization |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 |
{4}------------------------------------------------
{5}------------------------------------------------
Pre-clinical verification and validation tests results:
| Test | Results | Conclusions |
|---|---|---|
| ISO MTS Cytotoxicity.Report n° 199740 | Percentage viability of test article: 86.4% | No cytotoxic potential |
| ISO Intracutaneous Study in Rabbits -Two Extracts.Report n° 199741 | The 0.9% NaCl extract of the test article did notinduce any erythema or edema reactions afterinjection by intracutaneous route inthe rabbit.The sesame oil extract of the test article did notinduce more erythema and edema reactions thanthe vehicle alone after injection byintracutaneous route in the rabbit. | No erythema or edemareactions |
| ISO Acute Systemic Toxicity Study inMice - Two Extracts.Report n° 199743 | No body weight loss greater than 10% occurred,no abnormal behaviour was noted and bodyweight gains were thereafter observed until theend of the study.All animals appeared clinically normal at thebeginning and throughout the study. | No evidence of significantsystemic toxicity ormortality |
| ISO Guinea Pig MaximizationSensitization Test - Two Extracts.Report n° 199742 | 0.9% NaCl extract: sensitization grade 0Sesame oil extract: sensitization grade 0All animals appeared clinically normal throughoutthe study. | The test article was notconsidered a sensitizer inthe guinea pigmaximization model |
| Validation of the Manual CleaningProcess According to the ISO 17664standard and the AAMI TIR 30 TechnicalReport.Report n° 199900 | No soil was observed.No protein (<6.4 µg/cm²) was detected.No hemoglobin (<2.2 µg/cm²) was detected. | The manual cleaningprocess is validated. |
| Validation of the Automated CleaningProcess According to the ISO 17664standard and the AAMI TIR 30 TechnicalReport.Report n° 200220 | No soil was observed.No protein (<6.4 µg/cm²) was detected.No hemoglobin (<2.2 µg/cm²) was detected. | The automated cleaningprocess is validated. |
| Steam sterilization Study for theSPINEART OTELO Retractor Set.Report n° 154535-002 rev 1 | Sterilization Parameters ( 132° 2') provide a SALnot less than 10⁻⁶.No moisture was observed after dry time of 30'. | Steam sterilizationparameters 132°C, 4'anddry time 30' are validated |
{6}------------------------------------------------
| Mechanical performances - VerificationTest report n°VRR67-01-00 | Minimal opening of 100 mm is obtained.No breakage of the blades.No disassembly of the blades and the retractor.No disassembly of the arms of the retractor.No breakage or damage of the teeth of the rack.No breakage or damage of the thread feature ofthe knobs.Minimal opening of 46 mm is obtained.No breakage or damage of the thread feature ofthe knobs.No rotation or malfunction of the 4th bladeassembly.No disassembly of the shim pin from the shimtool.No disassembly of the shim pin from the blade. | Mechanical characteristicsare conform to the needs. |
|---|---|---|
| Functionality performances - ValidationTest report n°VLR67-08-00 | The light system worked well.Radiolucency is a clear advantage of the system.The arm, the base arm and the attachmentworked well. It has been commented that thearm attachment should be connected to the armbefore attaching to the retractor body.The multi-function double hex driver was wellappreciated for the posterior blade manipulation.The ratcheting mechanism and the toe-ing of theblades worked well.The 4th blade attachment is well designed.Posterior Shim and Shim pin worked correctly | Functionality is conform tothe needs. |
Discussion:
Differences of technical characteristics between subject device and predicate device:
The main differences between the two systems are limited to:
- A the material used for blades (CF/PEEK for OTELO versus stainless steel for predicate device),
- A the length of the range of blades (90 to 150 mm for OTELO versus 40 to 80 mm for predicate device),
- A the complementary distraction system that can be used to increase surgeon 's visibility access,
-
the cranial-caudal opening range (21 mm to 100 mm for OTELO versus 30 to 52 for predicate device).
Safety and effectiveness:
Material: Based on pre-clinical biocompatibility verification tests (reports n°199740, 199742 and 199743), it has been demonstrated that CF/PEEK material is conforming to ISO 10993-1 for contact inferior to 24 hours.
Length of blade: longer blades (90 to 180 mm) have been designed in order to provide a lateral access to the spine. Based on pre-clinical mechanical verification tests (report n°VRR67-01-00) and pre-clinical validation test (report n° VLR67-08-00), it has been demonstrated that mechanical characteristics for OTELO is conforming to the needs and indications for use.
Complementary distraction system: Based on pre-clinical mechanical verification tests (report n°VRR67-01-00) and pre-clinical validation test (report n° VLR67-08-00), it has been demonstrated
{7}------------------------------------------------
that mechanical characteristics of the complementary system for OTELO is conforming to the needs and indications for use.
Cranial-caudal opening: Based on pre-clinical mechanical verification tests (report n°VRR67-01-00) and pre-clinical validation test (report n° VLR67-08-00), it has been demonstrated that mechanical characteristics for OTELO is conforming to the needs and indications for use.
Conclusion:
The significant differences between the OTELO retractor system and the other mentioned marketed system which would adversely affect the safety and performances of the product have been tested in order to demonstrate OTELO capabilities.
The Spineart OTELO retractor system is substantially equivalent in design, function, mechanical performances and intended use, to the existing previously cleared spinal devices, MAST QUADRANT Retractor System by Medtronic Sofamor Danek (K043602).
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.