(154 days)
Not Found
No
The device description and performance studies focus on mechanical properties, cleaning, sterilization, and biocompatibility of manually operated surgical instruments. There is no mention of AI or ML in the document.
No
Explanation: The device is described as a surgical instrument used for cutting or biting bone during surgery. It is a tool used for a surgical procedure, not a device that provides therapy or treatment itself.
No
The device is described as surgical instruments used for cutting or biting bone during surgery, not for diagnosing medical conditions.
No
The device is described as manually operated, reusable surgical instruments made of stainless steel, with various physical configurations. This clearly indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are used for "cutting or biting bone during surgery involving the skull or spinal column." This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details surgical instruments (rongeurs) used for physical manipulation of bone. This is consistent with surgical tools, not diagnostic devices that analyze samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
Product codes (comma separated list FDA assigned to the subject device)
HAE, HTX
Device Description
The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:
- Different handles (Large, Standard, for use with Rotating Shafts) ●
- Different shaft lengths (6-14 inches) ●
- Different Bite Sizes (0.5-6 mm) .
- Different Angles (40° and 90°, up and down) .
- Different Footplates (Standard, Thin and Ultra-Thin)
- With or without ejector
- . Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull or spinal column
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical Strength
Test Summary: The Fehling Punches (predicate) were subject to static and dynamic mechanical testing to demonstrate fatigue resistance and cutting displacement in relation to force applied.
Result: The subject device is identical to the predicate in materials, manufacture, design, and function. No further mechanical testing was conducted.
Cleaning
Test Summary: A cleaning validation was performed on worst case instrument per the process provided in the IFU.
Result: Instruments were free of visible soil and met acceptance criteria for protein and hemoglobin content per AAMI TIR 30:2011.
Sterilization
Test Summary: A steam sterilization validation was performed using the half cycle approach.
Result: Sterilization parameters will provide a sterility assurance level of 10-6.
Biocompatibility
Test Summary: The predicate device was deemed biocompatible. The subject device is identical to the predicate in materials, manufacturing processes, manufacturer, sterilization, and technical specifications.
Result: No further biocompatibility testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Fehling Punches (K153243), Integra Kerrison Rongeurs (K150428)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 21, 2020
Ace Medical % Cassandra Petrov Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K200387
Trade/Device Name: Ace Medical Surgical Instruments Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE, HTX Dated: June 15, 2020 Received: June 19, 2020
Dear Cassandra Petrov:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Adam D. Pierce -S 2020.07.21 14:23:56 -04'00'
Adam D. Pierce, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200387
Device Name Ace Medical Surgical Instruments
Indications for Use (Describe)
The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
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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3
510(k) Summary
| Submitted By: | Ace Medical Co.
2230 Park Ave. #202
Cincinnati, OH 45206 |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 21, 2020 |
| Contact Person:
Contact Telephone:
Contact Fax: | Cassandra Petrov, Regulatory Engineer
(440) 541-0060
(440) 933-7839 |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Predicate Device: | Ace Medical Surgical Instruments
882.4840 Manual Rongeur, 888.4540 Orthopedic Manual Surgical Instrument
Class II , Class I
Neurology, Orthopedic
HAE, HTX
Fehling Punches (K153243)
Integra Kerrison Rongeurs (K150428) |
| | The predicate device has never been subject to recall. |
Device Description:
The Ace Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (ATTiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:
- Different handles (Large, Standard, for use with Rotating Shafts) ●
- Different shaft lengths (6-14 inches) ●
- Different Bite Sizes (0.5-6 mm) .
- Different Angles (40° and 90°, up and down) .
- Different Footplates (Standard, Thin and Ultra-Thin)
- With or without ejector
- . Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
Intended Use:
The Ace Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
4
Summary of Technological Characteristics:
The Ace Medical Surgical Instruments are identical to the predicate as they are manufactured by the same company, have the same intended use and the same fundamental scientific technology. Both devices are identical in several aspects which are summarized in the table below. A more detailed comparison of the Ace Medical Surgical Instruments with predicate and reference predicate devices is included in this submission.
Table 1. Technological Characteristics Comparison
Verification and Validation Testing:
| Test | Test Summary | Result |
|---|---|---|
| Mechanical Strength | The Fehling Punches (predicate) | The subject device is identical to |
| were subject to static and | the predicate in materials, | |
| dynamic mechanical testing to | manufacture, design, and | |
| demonstrate fatigue resistance |
5
| | and cutting displacement in
relation to force applied. | function. No further mechanical
testing was conducted. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Cleaning | A cleaning validation was
performed on worst case
instrument per the process
provided in the IFU. | Instruments were free of visible
soil and met acceptance criteria
for protein and hemoglobin
content per AAMI TIR 30:2011. |
| Sterilization | A steam sterilization validation
was performed using the half
cycle approach. | Sterilization parameters will
provide a sterility assurance
level of 10-6. |
| Biocompatibility | The predicate device was
deemed biocompatible. The
subject device is identical to the
predicate in materials,
manufacturing processes,
manufacturer, sterilization, and
technical specifications. | No further biocompatibility
testing is required. |
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.