(257 days)
Not Found
No
The summary describes a mechanical retractor system and its performance testing, with no mention of AI or ML capabilities.
No
The device is a retractor system designed to provide surgical access to the spine by retracting tissue, not to treat a disease or condition itself.
No
Explanation: The device description states its purpose is to provide "access to the spine by dissection and traction of soft and bony tissue" and "as a retracting device to maintain the access." This describes a surgical tool for tissue manipulation and retraction, not for detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a "tubular-based retraction system" and includes "instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device." This indicates a physical hardware device, not software.
Based on the provided information, the OTELO LL Retractor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide surgical access to the spine by dissecting and retracting soft and bony tissue. This is a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a tubular-based retraction system used for surgical access and visualization. This aligns with a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The OTELO LL Retractor's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAD
Device Description
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.
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)
Pre-clinical verification and validation tests were conducted.
- ISO MTS Cytotoxicity: Percentage viability of test article: 86.4%. Conclusion: No cytotoxic potential.
- ISO Intracutaneous Study in Rabbits - Two Extracts: The 0.9% NaCl extract and sesame oil extract of the test article did not induce erythema or edema reactions. Conclusion: No erythema or edema reactions.
- ISO Acute Systemic Toxicity Study in Mice - Two Extracts: No body weight loss greater than 10%, no abnormal behavior, and animals appeared clinically normal. Conclusion: No evidence of significant systemic toxicity or mortality.
- ISO Guinea Pig Maximization Sensitization Test - Two Extracts: 0.9% NaCl extract: sensitization grade 0; Sesame oil extract: sensitization grade 0. All animals appeared clinically normal. Conclusion: The test article was not considered a sensitizer in the guinea pig maximization model.
- Validation of the Manual Cleaning Process According to the ISO 17664 standard and the AAMI TIR 30 Technical Report: No soil, protein (
§ 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.
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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
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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) |
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510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | New devices |
| Submitted by | SPINEART |
| International Center Cointrin | |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 570 1246 Fax : +41 22 799 4026 | |
| Mail : fpennesi@spineart.com | |
| Regulatory 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 by |
| Medtronic Sofamor Danek |
| Design features | OTELO LL retractor by SPINEART | MAST QUADRANT Retractor system
by 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 system
by Medtronic |
| Indications for use | The OTELO®LL Retractor is intended to provide
the surgeon access to the spine by dissection
and traction of soft and bony tissue. | The MAST QUADRANT™ Retractor System is
intended to provide surgeons with
instruments such as dilators, retractors,
light sources and pedicle access needles
used to perform a variety of spinal fixation
procedures utilizing a minimally invasive
approach. The MAST QUADRANT™
Retractor System is indicated for
visualization of the surgical field in any area
of the body cut open during a surgical
procedure. When used in the cervical,
thoracic, or lumbar spine either from an
anterior or posterior direction, for example,
the MAST QUADRANT™ Retractors and
accessories are intended to aid the
surgeon's visualization of the surgical area
and allow him/her to perform any type of
surgical spinal procedure such as herniated
disc repair, visualization of the
circumferential decompression of the nerve
roots, aiding in the search and removal of
nucleus material, spinal fusion, or insertion
of spinal implants. |
| Description | 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. | The MAST QUADRANT™ 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
MAST QUADRANT™ 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. |
| Material | Stainless Steel, PEEK and PEEK Carbon. | Stainless Steel |
| Design features | Self-locking mechanism and minimal invasive
use | Self-locking mechanism and minimal
invasive use |
| Operating
principle | Gives surgeons an easy access and good
visualization of the disc to be treated. | Gives surgeons an easy access and good
visualization of the disc to be treated. |
| Technological
characteristics | The retractor system is composed of one
retractor base associated to different
instruments such as dilators tube, blades,
wires, retractor, shim pins, light source and
flex arm attachment. Range of blades is
composed of 10 right, 10 left and 10 posterior
blades which varies from 90 to 180 mm length.
If needed, a fourth blade distraction system
can be adapted in order to increase surgeon's
access visibility. This complementary system is
composed of 2 wide and 2 narrow
supplemental blades which varies from 5 to 10
mm width. | The retractor system is composed of one
retractor base associated to different
instruments such as dilators tube, blades,
wires, retractor, light source and flex arm
attachment. Range of blades is composed of
5 right and 5 left blades which varies from
40 to 80 mm length. If needed, a
complementary medial /lateral distraction
system can be adapted in order to increase
surgeon's access visibility. This
complementary system is composed of 3
wide and 3 narrow supplemental blades
which varies from 50 to 90 mm length |
| Design features | OTELO LL retractor by SPINEART | MAST QUADRANT Retractor system
by Medtronic |
| Ranges of the
retractor opening
distance | Antero-posterior opening range: 21 mm to 46
mm
Cranial-caudal opening range: 21 mm to 100
mm | Cranial-caudal opening range: 30 mm to 52
mm |
| Ranges of blade
angle | Cranial-Caudal inclination angle range:
0° to +15° | / |
| Packaging | Instruments are individually packaged in
polyethylene sealed pouch with label and IFU
included.
When packaged as an Instrument set, the set
is packaged in polyethylene sealed pouch with
label and IFU included. | Same for non sterile instruments. |
| Shelf life | Not applicable. Devices are provided non
sterile. | / |
| Sterilization | Steam sterilization | Steam sterilization |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 |
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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 not | |
| induce any erythema or edema reactions after | ||
| injection by intracutaneous route in | ||
| the rabbit. | ||
| The sesame oil extract of the test article did not | ||
| induce more erythema and edema reactions than | ||
| the vehicle alone after injection by | ||
| intracutaneous route in the rabbit. | No erythema or edema | |
| reactions | ||
| ISO Acute Systemic Toxicity Study in | ||
| Mice - Two Extracts. | ||
| Report n° 199743 | No body weight loss greater than 10% occurred, | |
| no abnormal behaviour was noted and body | ||
| weight gains were thereafter observed until the | ||
| end of the study. | ||
| All animals appeared clinically normal at the | ||
| beginning and throughout the study. | No evidence of significant | |
| systemic toxicity or | ||
| mortality | ||
| ISO Guinea Pig Maximization | ||
| Sensitization Test - Two Extracts. | ||
| Report n° 199742 | 0.9% NaCl extract: sensitization grade 0 | |
| Sesame oil extract: sensitization grade 0 | ||
| All animals appeared clinically normal throughout | ||
| the study. | The test article was not | |
| considered a sensitizer in | ||
| the guinea pig | ||
| maximization model | ||
| Validation of the Manual Cleaning | ||
| Process According to the ISO 17664 | ||
| standard and the AAMI TIR 30 Technical | ||
| Report. | ||
| Report n° 199900 | No soil was observed. | |
| No protein ( 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).