(259 days)
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.
When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection.
The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert.
The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.
The provided text describes a 510(k) premarket notification for a surgical device, not an AI or imaging diagnostic device. Therefore, the information typically required for describing the acceptance criteria and study proving device performance for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, effect size, standalone performance, ground truth types) is not present in this document.
This submission focuses on demonstrating substantial equivalence to predicate devices for a mechanical surgical instrument based on its physical characteristics, materials, and functional testing.
Here's an analysis of what is available regarding acceptance criteria and performance:
1. Acceptance Criteria and Reported Device Performance (based on mechanical and biocompatibility testing)
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safety of patient-contacting materials (e.g., non-toxic, non-irritating, non-sensitizing). Adherence to GLP. | "A series of biocompatibility tests demonstrated the safety of the OCM Burr Support Sleeves patient contacting materials. All tests were conducted in accordance with the GLP regulation (21 CFR Part 58)." |
| Functionality/Performance | Proper functionality after repeated use; safe external temperatures; effective cleaning and sterilization; proper cutting/shaping of bone. | "Several performance tests demonstrated the safety and effectiveness of the OCM Attachment and OCM Burr Support Sleeves. Specifically, OCM Attachment testing demonstrated proper functionality after repeated use, safe external temperatures, and the ability to clean and sterilize effectively without adverse effects on functionality or performance. OCM Burr Support Sleeves testing demonstrated proper functionality and safe external temperatures. In addition, a simulated use study demonstrated both the OCM Attachment and the OCM Burr Support Sleeves perform as intended in cutting and shaping bone properly." |
| Equivalence | Demonstrated substantial equivalence to identified predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness. | The entire 510(k) submission serves as the proof for this. The conclusion states: "Scientifically valid data demonstrates that the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems with the ANSPACH® Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves is as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the requested indication." The FDA's letter confirms the determination of substantial equivalence. The technological characteristics are stated to be "no new technological characteristics" and the new indications are "consistent with numerous other currently marketed surgical drill systems and accessories." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as numerical sample sizes for "test sets" in the context of an AI/diagnostic device. For this surgical instrument, testing would involve a certain number of units for various mechanical, thermal, and biocompatibility tests. For example, "a series of biocompatibility tests" and "several performance tests" imply multiple tests on one or more samples, but specific quantities are not provided.
- Data Provenance: The tests were likely conducted internally by The Anspach Effort, Inc. or by contract labs on their behalf, in accordance with regulatory standards (e.g., GLP for biocompatibility). The country of origin and retrospective/prospective nature are not specified, but typically this would be a prospective testing program for a new medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a mechanical surgical device as there's no "ground truth" to be established by clinical experts in the same way as an AI diagnostic algorithm for image interpretation. The performance is assessed through objective physical and biological tests. A "simulated use study" implies assessment by skilled personnel, possibly surgeons or engineers, but their qualifications and numbers are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept belongs to studies where human experts are making subjective judgments (e.g., reading medical images) that need to be reconciled. For mechanical device testing, outcomes are typically measured quantitatively against defined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is specific to AI/diagnostic imaging devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is specific to AI/diagnostic algorithms. The device is a physical surgical instrument that always requires a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through objective test methods and specifications. For instance:
- Biocompatibility: Adherence to ISO standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization), with results compared against pass/fail criteria.
- Functionality: Measurements of power, speed, temperature, durability (after repeated cycles), efficacy of cleaning/sterilization methods, and successful cutting/shaping of target material (e.g., bone surrogate) as intended.
- Simulated Use: Demonstration that the device "perform[s] as intended in cutting and shaping bone properly." This would likely involve visual inspection and perhaps quantitative assessment of the cutting performance on a model.
8. The sample size for the training set
Not applicable. This refers to AI model development.
9. How the ground truth for the training set was established
Not applicable. This refers to AI model development.
In summary: This 510(k) submission relies on demonstrating substantial equivalence through a combination of:
- Comparison of technological characteristics with predicate devices.
- Biocompatibility testing to assure material safety.
- Performance testing to demonstrate proper functionality, thermal safety, durability, and effectiveness in simulated use, aligning with the intended purpose and implicitly meeting industry standards for such devices.
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DEC 3 1 2013
510(k) PREMARKET NOTIFICATION ANSPACH® Systems with Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves
510(k) Summary
| SubmitterInformation | Company: | The Anspach Effort, Inc.4500 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|---|
| Contact Person: | Jeannette G. DaileyRegulatory Affairs Manager | |
| Email: | Dailey.Jeannette@synthes.com | |
| Telephone: | 561-494-3710 | |
| FAX: | 561-625-9110 | |
| Date Prepared: | November 8, 2013 | |
| Identification ofthe Device | Common Names: | Pneumatic and Electric Surgical Instrumentsand Attachments |
| Device Name: | ANSPACH® XMax Pneumatic and eMax 2 andeMax2 Plus Electric Systems with theANSPACH® Otologic Curved Micro (OCM)Attachment and OCM Burr Support Sleeves | |
| Classification Names: | • Ear, nose and throat electric or pneumaticsurgical drill• Ear, nose and throat bur | |
| Device Classification: | • Class II, 21 CFR 874.5250 (drill)• Class 1, 510(k) exempt, 21 CFR 874.4140 (bur) |
Predicate Devices(s) The subject devices are substantially equivalent to the following predicate devices:
The electric and pneumatic surgical drills are identical to the currently marketed electric and pneumatic surgical drills:
- ANSPACH® XMax Pneumatic System cleared via K965080 .
- ANSPACH® eMax 2 and eMax2 Plus Electric Systems cleared via . K011444
The Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves are substantially equivalent to the handpiece and burrs associated with the:
- . Medtronic. Inc., XPS® 3000 System cleared most recently via K073255 on March 24, 2008
Continued on next page
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510(k) Summary, Continued
| Description of Device | The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection. |
|---|---|
| The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert. | |
| The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only. | |
| Indications for Use | The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium. |
| When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies. |
Continued on next page
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510(k) Summary, Continued
| TechnologicalCharacteristics | There are no new technological characteristics associated with theANSPACH® Pneumatic and Electric Systems, the OCM Attachmentand the OCM Burr Support Sleeves. The ANSPACH® XMaxPneumatic and eMax 2 and eMax2 Plus Electric Surgical Drills areidentical to the currently marketed electric and pneumatic surgical drills.The new ANSPACH® Otologic Curved Micro (OCM) Attachment andOCM Burr Support Sleeves utilize the same biocompatible materials ascurrently marketed attachments and burrs. The packaging,manufacturing method, and cleaning and sterilization methods of theOCM Attachment are the same as currently marketed ANSPACH® |
|---|---|
| attachments. The OCM Burr Support Sleeves packaging,manufacturing method and sterilization method are also the same ascurrently marketed ANSPACH® burrs.The new indications for use are consistent with numerous othercurrently marketed surgical drill systems and accessories. | |
| Non-ClinicalTesting | A series of biocompatibility tests demonstrated the safety of the OCMBurr Support Sleeves patient contacting materials. All tests wereconducted in accordance with the GLP regulation (21 CFR Part 58).Several performance tests demonstrated the safety and effectiveness ofthe OCM Attachment and OCM Burr Support Sleeves. Specifically,OCM Attachment testing demonstrated proper functionality afterrepeated use, safe external temperatures, and the ability to clean andsterilize effectively without adverse effects on functionality orperformance. OCM Burr Support Sleeves testing demonstrated properfunctionality and safe external temperatures. In addition, a simulateduse study demonstrated both the OCM Attachment and the OCM BurrSupport Sleeves perform as intended in cutting and shaping boneproperly. |
| Conclusions | Scientifically valid data demonstrates that the ANSPACH® XMaxPneumatic and eMax 2 and eMax2 Plus Electric Systems with theANSPACH® Otologic Curved Micro (OCM) Attachment and OCM BurrSupport Sleeves is as safe and effective as the predicate devices whenused in accordance with the labeled directions for use and for therequested indication. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
December 31, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
The ANSPACH Effort, Inc. % Ms. Annette M. Hillring 3012 St. Charles Drive Tampa, FL 33618
Re: K131053
Trade/Device Name: ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electrical Systems with Otologic Attachment System (Otologic Attachment and Curved Burrs) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL; EQJ Dated: November 26, 2013 Received: December 2, 2013
Dear Ms. Hillring:
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.
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Page 2 - Ms. Annette M. Hillring
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/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 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.
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear,
Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131053
Device Name: ANSPACH® XMax Pneumatic and eMax2 and eMax2 Plus Electrical Systems with Otologic Attachment System
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Indications for Use: Electric Systems are intended for cutting and shaping bone including spine and cranium.
When used with the ANSPACH® Systems, the OCM Attachment and OCM Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sageev George -S 2013.12.27 17:13:53 -05'00'
Page of of
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.