(27 days)
P120024
No
The description focuses on manual surgical instruments for implantation and does not mention any AI/ML capabilities or image processing.
No.
The device is described as "manual surgical instruments which aid in selecting, placing, and revising the activL® device," indicating they are tools for implantation rather than devices that directly treat a condition.
No
The device description clearly states it consists of "manual surgical instruments which aid in selecting, placing, and revising the activL® device." This indicates its role in implantation and manipulation, not diagnosis. The "Intended Use / Indications for Use" section also confirms its purpose is for "successful implantation," manipulating tissue, and positioning/removal of the activL® device. There is no mention of analysis, detection, or interpretation of a medical condition.
No
The device description explicitly lists physical surgical instruments (trial, trial holders, chisels, inserter, etc.) and the performance studies focus on functional testing, transit testing, and sterilization/cleaning validation, all indicative of hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are for the implantation of a surgical device (the activL® device) and for manipulating tissue or implant materials during surgery. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description lists surgical instruments like trials, chisels, inserters, etc., which are used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.
Product codes
QLQ
Device Description
The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
activL® Next Generation Instrumentation have been evaluated via the following performance testina:
- Simulated use/Functional testing
- . Transit testing
- . Sterilization/Cleaning validation
The results demonstrated the performance of activL® Next Generation Instrumentation is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
P120024
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 the FDA logo, which 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 13, 2023
Aesculap Implants Systems LLC Hamza Ahmed Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K231769
Trade/Device Name: activL® Next Generation Instrumentation Regulation Number: 21 CFR 888.4515 Regulation Name: Orthopedic manual surgical instrumentation for use with total disc replacement devices Regulatory Class: Class II Product Code: QLQ Dated: June 16, 2023 Received: June 16, 2023
Dear Hamza Ahmed:
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.
1
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 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 mediation-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.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231769
Device Name
activL® Next Generation Instrumentation
Indications for Use (Describe)
The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.
| 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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510(k) Summary
| Device Trade Name: | activL® Next Generation Instrumentation |
|---|---|
| Manufacturer: | Aesculap Implant Systems, LLC |
| 3773 Corporate Pkwy | |
| Center Valley, PA 18034 | |
| Contact Person: | Hamza Ahmed |
| Specialist, Regulatory Affairs | |
| Aesculap Implant Systems, LLC | |
| 3773 Corporate Pkwy | |
| Center Valley, PA 18034 | |
| Phone: (610) 737-3900 | |
| Hamza.Ahmed@bbruanusa.com | |
| Date Prepared: | July 12, 2023 |
| Registration Number: | 3005673311 |
| Product Code: | QLQ |
| Classifications: | Class II - 21 CFR §888.4515 |
| Classification Name: | Orthopedic manual surgical instrumentation for use with total disc |
| replacement devices | |
| Predicate Device(s): | Primary - K220861 M6-C Artificial Cervical Disc Instruments |
| (Approved via PMA P170036 and reclassified in Q200722) | |
| Reference – P120024 activL Artificial Disc |
Reason for the 510(k) Submission: Design Changes to activL® Trials, activL® Trial Holders, activL®Depth Stop, activL® Trial Inserter, activL® Single and Double Chisels, activL® Impaction Caps, activL® Depth Stop Driver, and activL® Implant Inserter
Device Description:
The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.
4
Indications for Use:
The Aesculap Implant Systems activL® Next Generation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.
Performance Testing Summary:
activL® Next Generation Instrumentation have been evaluated via the following performance testina:
- Simulated use/Functional testing
- . Transit testing
- . Sterilization/Cleaning validation
The results demonstrated the performance of activL® Next Generation Instrumentation is substantially equivalent to the predicate devices.
Substantial Equivalence:
The subject device is substantially equivalent to the predicate devices with respect to indication, design, materials, function, and performance.
Conclusion:
activL® Next Generation Instrumentation have the same intended use, indications for use, technological characteristics as the predicate devices (K220861 / P170036 / Q200722, P120024), and the results of performance testing demonstrate the subject device do not introduce any new question of safety or effectiveness. Therefore, the activL® Next Generation Instrumentation is substantially equivalent to the cited predicate devices.