(78 days)
Synthes RIA System is intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis.
Synthes RIA System is a flexible intramedullary reaming and bone harvesting device with simultaneous irrigation and aspiration that consists of disposable tube assemblies, disposable reamer heads, disposable drive shaft seal, disposable locking clip, disposable graft filter and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation as well as the harvesting of bone and bone marrow, and as part of the treatment regimen for osteomyelitis.
The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the typical sense of a performance evaluation with metrics like sensitivity, specificity, etc. This document is a 510(k) summary for the Synthes RIA System, focused on establishing substantial equivalence to a predicate device and expanding its indications for use.
Instead of a traditional performance study, the substantial equivalence assertion is supported by a literature review demonstrating existing clinical practice and outcomes related to the expanded indications.
Therefore, many of the requested fields cannot be directly answered, as the nature of the submission is not a device performance study against predefined metrics.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly defined in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) revolve around demonstrating that the expanded indications for use (osteomyelitis treatment and adolescent use) are substantially equivalent to existing, legally marketed practices or devices.
- Reported Device Performance: No quantitative performance metrics are reported. The "performance" is implicitly demonstrated through the cited literature, which describes successful clinical application of intramedullary reaming and bone harvesting in the contexts of osteomyelitis and adolescent patients.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the collection of patients from various retrospective studies and case studies cited in the literature review.
- For osteomyelitis: 18 patients (Lidgren L, Torholm C), 25 patients (Ochsner PE, Gosele A, Buess P), 32 patients (Pape H-Ch, et. al.), 2 patients (Ilyas AM, Mudgal CS), 1 patient (Bellapianta J, et. al.), 11 patients (Zalavras CG, Sing A, Patzakis MJ), 1 patient (Cobbs KF) - with some overlap as Pape and Lidgren studies also reference adolescents.
- For adolescent use: 5 patients (Mehlman CT, Bishai SK), and "several" patients in other cited articles (Gordon JE, et. al.; Jencikova-Celerin L, et. al.; Keeler KA, et. al.), plus the adolescent patients from the Pape and Lidgren osteomyelitis studies.
- Data Provenance: Predominantly retrospective analyses and case studies, as clearly stated in the descriptions of the cited literature. The countries of origin are not specified for most studies, but the authors' names suggest a mix of international research.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth was not established by a panel of experts for a novel test set in this context. The "ground truth" is implied by the clinical outcomes reported in the independent literature, which would have been assessed by the clinicians (e.g., surgeons, radiologists) involved in those studies.
- Qualifications of Experts: Not specified for the individuals who originally published the cited literature. Presumably, they are orthopedic surgeons or similar medical specialists based on the nature of the research.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no formal adjudication process for a "test set" in this submission. The clinical findings and conclusions of the referenced peer-reviewed articles serve as the evidence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on demonstrating substantial equivalence through literature review, not on comparing the device's diagnostic or treatment effectiveness against a standard or human readers with AI assistance.
- Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no such study was performed or presented.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Standalone Performance Study: Not applicable. The Synthes RIA System is a manual surgical instrument, not an AI algorithm or a device requiring standalone performance metrics in this sense. Its effectiveness is intrinsically linked to its use by a human surgeon.
7. The Type of Ground Truth Used
- Type of Ground Truth: Clinical outcomes and expert observations documented in published medical literature (retrospective analyses, case studies). This can be categorized as a form of "outcomes data" and "expert consensus" derived from independent clinical research. For osteomyelitis, the ground truth would be the diagnosis and successful treatment (e.g., infection eradication, bone healing) reported by the treating clinicians in the cited studies. For adolescent use, it refers to the successful application of intramedullary reaming in this age group as reported in the literature.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The submission relies on existing clinical literature to support its expanded indications, not on a data-driven model.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device submission.
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510(k) Summary
Attachment B
AUG 1 0 2011
| Date Prepared: | August 9, 2011 | K111437 |
|---|---|---|
| Sponsor: | SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854 | |
| Device Name: | Synthes RIA System | |
| Classification: | Class II, 21 CFR §888.4540, Orthopedic manual surgical instrumentProduct Code: HTO & HRX | |
| Predicate Device: | Synthes RIA System (K042899) | |
| Device Description: | Synthes RIA System is a flexible intramedullary reaming and bone harvestingdevice with simultaneous irrigation and aspiration that consists of disposable tubeassemblies, disposable reamer heads, disposable drive shaft seal, disposable lockingclip, disposable graft filter and reusable drive shafts. The device is designed forexpedited reaming of the medullary canal in preparation for internal fixation as wellas the harvesting of bone and bone marrow, and as part of the treatment regimen forosteomyelitis. | |
| Intended Use: | Synthes RIA System is intended for use in adults and adolescents (12-21 years) toclear the medullary canal of bone marrow and debris and to effectively size themedullary canal for the acceptance of an intramedullary implant or prosthesis, toharvest finely morselized autogenous bone and bone marrow for any surgicalprocedure requiring bone graft to facilitate fusion and/or fill bone defects, and toremove infected and necrotic bone and tissue from the medullary canal in thetreatment of osteomyelitis. | |
| SubstantialEquivalence: | The intent of this 510(k) is to expand and clarify the indications for use statement ofthe Synthes RIA system, including the use of the device for removal of infected andnecrotic bone and tissue and use in the adolescent population.The following literature references were assessed in support of the substantialequivalence determination for the osteomyelitis addition to the indications for usestatement:• Retrospective analysis of the treatment of 18 cases of osteomyelitis in 17patients with treatment including reaming of the intramedullary canal between1974 and 1978 (Intramedullary Reaming in Chronic Diaphyseal Osteomyelitis: APreliminary Report, Lidgren L, Torholm C.)• Retrospective analysis of 25 patients treated for osteomyelitis with reaming ofthe intramedullary canal (The value of intramedullary reaming in the treatment ofchronic osteomyelitis of long bones, Ochsner PE, Gosele A, Buess P.) |
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| • Retrospective analysis of 32 patients treated for osteomyelitis, including intramedullary reaming between 1990 and 1991 (Chronic diaphyseal osteomyelitis of long bones refractory to conventional therapy – Benefits and risks of reaming of the femoral medullary cavity, Pape H-Ch, et. al.) |
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| • Retrospective review of two patients treated for humeral osteomyelitis, including intramedullary reaming (Management of Medullary Osteomyelitis of the Humerus, Ilyas AM, Mudgal CS) |
| • Case study of a 48 year old male treated for osteomyelitis with the RIA system (Use of the Reamer Irrigator Aspirator for the Treatment of 20-Year Recurrent Osteomyelitis of a Healed Femur Fracture, Bellapianta J, et. al.) |
| • Discussion on the use of the RIA System at a level-2 trauma center, including the use of treatment regimen of osteomyelitis (RIA: One Community's Experience, Finkemeier CG, Neiman R, Hallare D) |
| • Retrospective analysis of 11 patients treated between 2004 and 2005 for osteomyelitis including the use of the RIA system for debridement (Novel Technique for Medullary Canal Debridement in Tibia and Femur Osteomyelitis, Zalavras CG, Sing A, Patzakis MJ) |
| • Case study of a 37 year old man treated for recurrent infection, including the use of the RIA system for intramedullary reaming (RIA use in a community orthopedic trauma practice: applying technology, respecting biology, Cobbs KF) |
| • Several publications cited for inclusion of debridement as an integral aspect of the treatment regimen for osteomyelitis (Chronic Posttraumatic Osteomyelitis and Infected Nonunion of the Tibia: Current Management Concepts, Patzakis MJ, Zalavras CG; A Clinical Staging System for Adult Osteomyelitis, Cierny III G, Mader JT, Penninck JJ; Treatment of long bone intramedullary infection using the RIA for removal of infected tissue: Indications, method and clinical results, Zalavras CG, Sirkin M) |
| The following literature references were assessed in support of the substantial equivalence determination for the adolescent population addition to the indications for use statement: |
| • Case study of five patients discussing the placement of intramedullary nails in adolescent patients, including intramedullary reaming (Tibial Nails for Femoral Shaft Fractures in Large Adolescents with Open Femoral Physes, Mehlman CT, Bishai SK) |
| • Several publications cited to discuss the placement of intramedullary nails in adolescent patients, including intramedullary reaming (Intramedullary Nailing of Femoral Fractures in Children Through the Lateral Aspect of the Greater Trochanter Using a Modified Rigid Humeral Intramedulary Nail, Preliminary Results of a New Technique in 15 Children, Gordon JE, et. al; Flexible Interlocked Nailing of Pediatric Femoral Fractures, Experience with a New Flexible Interlocking Intramedullary Nail Compared with Other Fixation Procedures, Jencikova-Celerin L, et. al.; Antegrade Intramedullary Nailing of Pediatric Femoral Fractures Using an Interlocking Pediatric Femoral Nail and a Lateral Trochanteric Entry Point, Keeler KA, et. al.) |
| • Two of the articles referenced above for treatment of osteomyelitis included reference to adolescent patients (Pape and Lidgren studies) |
| • Case study of three patients within the population range trated for osteomyelitis, including reaming of the intramedullary canal (Infected Non-union of the Tibial Shaft Treated by Kuntschner Intramedullary Reaming and Nail Fixation, A |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is 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
Synthes (USA) Products, LLC % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
AUG 1 0 2011
Re: K111437
Trade/Device Name: Synthes USA RIA System Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: Class II Product Code: HRX, HTO Dated: May 03, 2011 Received: June 21, 2011
Dear Ms. Lassandro:
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. Ilsting 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
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Page 2 - Ms. Angela F. Lassandro
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Sincerely yours,
Mark A. Mellauson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
K11437 510(k) Number (if known):
Device Name: Synthes USA RIA System
Indications for Use:
Synthes RIA System is intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (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)
Neil K. Daylen for mam
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K111437
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(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 § 888.9.