(56 days)
No
The device is a manually operated surgical instrument with no mention of software, algorithms, or data processing capabilities.
No.
The device is a surgical instrument used for cutting or biting bone during surgery, which is an interventional procedure rather than a therapeutic one designed to treat a disease or condition itself.
No
Explanation: The device is a surgical instrument (rongeur) used for cutting or biting bone, not for diagnosing conditions or diseases.
No
The device description clearly states it is a reusable stainless steel instrument, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device description and intended use: The description clearly states that the Integra® Kerrison Rongeurs are "manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column." This is a surgical instrument used directly on the patient's body during a procedure, not for analyzing samples outside the body.
The information provided focuses on the physical characteristics of the instrument, its sterilization, and its intended surgical use. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Product codes
HAE
Device Description
Integra® Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles: regular and thin/low profile footplates: standard and eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.
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)
Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 20 minutes. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
Integra York PA, Inc. Ms. Stephanie Sheeslev Senior Manager, Regulatory Affairs 589 Davies Drive York, Pennsylvania 17402
Re: K150428
Trade/Device Name: Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: February 18, 2015 Received: February 19, 2015
Dear Ms. Sheesley,
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
1
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 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. 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
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,
Carlos L. Pena-S
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) K150428
Device Name
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs
Indications for Use (Describe)
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
Integra York PA, Inc. 589 Davies Drive York, PA 17402 USA
Phone: (717) 717-840-3522 Fax: (717) 840-9347
Contact Person: Stephanie Sheesley Date Prepared: April 15, 2015
II. DEVICE
Name of Device: Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs Common Name: Kerrison Rongeur Classification Name: Manual, Rongeur (21 CFR 882.4840) Regulatory Class: Class II Product Code: HAE
III. PREDICATE DEVICE
Integra® Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand® Kerrison Rongeurs, K092227
This predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
Integra® Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles: regular and thin/low profile footplates: standard and eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.
V. INDICATIONS FOR USE
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
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VI. COMPARISON OF TECHNOLOGICAL CHRACTERISTICS WITH THE PREDICATE DEVICE
| | Integra York PA, Inc.
Integra® Kerrison Rongeurs | Integra Medical Instrument Group
(now Integra York PA, Inc.)
Integra® Kerrison Rongeurs | |
|------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| 510(k) # | Subject of Submission | K092227 | |
| Class | II | II | |
| Pro Code | HAE | HAE | |
| Regulation # | 882.4840 | 882.4840 | |
| Classification | Manual, Rongeur | Manual, Rongeur | |
| Indications for Use | Kerrison Rongeurs are manually | Kerrison Rongeurs are manually | |
| | operated instruments indicated for | operated instruments indicated for | |
| | cutting or biting bone during surgery | cutting or biting bone during surgery | |
| | involving the skull or spinal column. | involving the skull or spinal column. | |
| Contact Materials | 420 Stainless steel | 420 Stainless steel | |
| | Surface coatings: Titanium | Surface coatings: Titanium | |
| | Nitride(TiN); Diamond Coat and Hard- | Nitride(TiN); Diamond Coat and Hard- | |
| | Coat™ (TiAIN): Stealth Coat and | Coat™ (TiAIN); Stealth Coat and | |
| | Smooth-Coat™ (Dicronite DL-5); | Smooth-Coat™ (Dicronite DL-5); | |
| | Ultra-Coat™ (ZrN); PTFE | Ultra-Coat™ (ZrN); PTFE | |
| | (polytetrafluoroethylene [Teflon®]); | (polytetrafluoroethylene [Teflon®]); | |
| | Silicone (Elastosil® LR3003/80 A,B) | Silicone (Elastosil® LR3003/80 A,B) | |
| Instructions for Use | Sterilize in either the Assembled or | Sterilize in Disassembled. Open | |
| | Disassembled, Open Position. | Position. | |
| | Successful Sterilization Validation | | |
| | supports Assembled and Open | | |
| | Configuration | | |
| Technological | Identical to Predicate | Manual, non-electrical, non-sterile, | |
| Characteristics | | reusable | |
| Malleability | Non-malleable | Non-malleable | |
| Sterility | Non-sterile | Non-sterile | |
| Sterilization | Sterilizable | Sterilizable | |
| Utility | Reusable | Reusable | |
| Energy Source | N/A (manual) | N/A (manual) | |
| Image of Example | | | |
| Kerrison Rongeur -
Detach Shaft | | | |
| | | | |
| | | | |
The below table provides a comparison of the subject devices and the predicate devices.
There are no differences in technology, materials, intended use, or design between the subject devices and the above predicates. The only change is with respect to the labeling. The Instructions For Use for the predicate device stated that the device was to be sterilized in the disassembled but open configuration. The Instructions for Use for the subject devices allows the devices to be sterilized in the either the disassembled, but open configuration. This change is supported by a successful sterilization validation.
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VII. PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. No new testing was required to be performed in support of this labeling change. This Special 510(k) pre-market notification includes the sterilization validation submitted with the predicate device submission #K092227 as a reference only.
The below testing is provided as a reference to support the labeling change subject to this Special 510(k). This testing is not new and was previously included in the 510(k) submission #K092227 and was deemed acceptable to support the proposed labeling change per Pre-Submission #Q141112.
| Testing Performed | Results |
|---|---|
| Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 | |
| & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure | |
| Time of 4 minutes and Drying Time of 20 minutes | Pass |
No biocompatibility testing was performed as a result of this Special 510(k) as the subject devices are not under-going a change in materials - this submission is for a labeling change only.
VIII. CONCLUSIONS
The labeling was the only change submitted under this Special 510(k) and supports the substantial equivalence to the predicate device.