(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 software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a surgical instrument used for cutting or biting bone during surgery. Its function is to perform a surgical action, not to provide therapy or treatment itself.
No
The device is described as surgical instruments used for cutting or biting bone, which indicates an operative or therapeutic function, not a diagnostic one.
No
The device description clearly states it is a manually operated, reusable surgical instrument made from stainless steel, describing various physical configurations and materials. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Wiggins Medical Surgical Instruments are "manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column." This describes a device used directly on the patient's body during a surgical procedure.
- Lack of IVD Characteristics: The document does not mention any analysis of biological specimens, laboratory testing, or diagnostic information derived from samples.
Therefore, based on the provided information, the Wiggins Medical Surgical Instruments are surgical instruments used for direct intervention on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Wiggins 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 Wiggins 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 (AITiN) 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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2020
Wiggins Medical % Cassandra Petrov Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K200383
Trade/Device Name: Wiggins 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 vour 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
1
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 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).
Sincerely,
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) K200383
Device Name Wiggins Medical Surgical Instruments
Indications for Use (Describe)
The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
X 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: | Wiggins Medical
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: | Wiggins 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 Wiggins 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 (AITiN) 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 Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
Summary of Technological Characteristics:
The Wiggins 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
4
comparison of the Wiggins Medical Surgical Instruments with predicate and reference predicate devices is included in this submission.
| Item | Wiggins Medical
Instruments | Fehling Punches | Integra
Kerriosn
Rongeurs | Equivalence |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended Use | The Wiggins Medical
Surgical Instruments
are manually
operated, reusable
surgical instruments
used for cutting or
biting bone during
surgery involving the
skull or spinal
column. | Manually operated
instruments indicated
for cutting or biting
bone during surgery
involving the skull or
spinal column | Manually
operated
instruments
indicated
for cutting
or biting
bone
during
surgery
involving
the skull or
spinal
column | Equivalent |
| Manufacturer | Gebruder Zepf
Medizentechnik
GmbH & Co. KG | Gebruder Zepf
Medizentechnik
GmbH & Co. KG | Unknown | Equivalent |
| Design | Rongeur with a fixed
and a sliding shaft
and angled footplate | Rongeur with a fixed
and a sliding shaft
and angled footplate | Rongeur
with a
fixed and a
sliding
shaft and
angled
footplate | Equivalent |
| Design Features | Manual, non-
electrical, non-sterile,
reusable, non-
malleable | Manual, non-
electrical, non-sterile,
reusable, non-
malleable | Manual.
non-
electric,
reusable,
non-
malleable | Equivalent |
| Materials | 420 and 304 Stainless
Steel (ASTM F-899),
Surface Coating-
CERAMO®
(TiAIN); Silicone | 420 and 304 Stainless
Steel (ASTM F-899),
Surface Coating-
CERAMO®
(TiAIN); Silicone | 420
Stainless
steel | Equivalent |
Table 1. Technological Characteristics Comparison
Verification and Validation Testing:
| Test | Test Summary | Result |
|---|---|---|
| Mechanical Strength | The Fehling Punches (predicate) | |
| were subject to static and | ||
| dynamic mechanical testing to | ||
| demonstrate fatigue resistance | The subject device is identical to | |
| the predicate in materials, | ||
| manufacture, design and | ||
| function. No further mechanical | ||
| testing was conducted. |
5
| | and cutting displacement in
relation to force applied. | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 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.