(270 days)
FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.
The Subject device is a kit comprised of a bone and marrow harvesting needle, collection jar, suction tubing, drill-tip guide pin, and bone void filler hydration chamber. The FORCYTE system harvests autologous bone and marrow for use as a bone void filler.
Based on the provided FDA 510(k) clearance letter for the Forcyte Autograft Harvest Kit (K243407), the device is a Gastroenterology-Urology Biopsy Instrument. The letter explicitly states that "No clinical evaluations were conducted" for this device. This means that the 510(k) clearance relies solely on non-clinical (bench) testing, and therefore, it is not possible to provide acceptance criteria or a study description related to AI algorithm performance or diagnostic accuracy, human reader performance, or multi-reader multi-case (MRMC) comparative effectiveness studies from this document.
The information requested in the prompt (AI algorithm performance data, expert ground truth, MRMC studies, etc.) is typically associated with software as a medical device (SaMD) or AI/ML-enabled devices that perform diagnostic or prognostic functions based on image analysis, pattern recognition, etc. The Forcyte Autograft Harvest Kit, however, is a physical instrument for harvesting bone and bone marrow.
Therefore, many of the requested items are not applicable to the information provided in this 510(k) clearance letter. I will address the relevant points based on the document's content and explicitly state when information is not available.
Analysis of the Forcyte Autograft Harvest Kit (K243407) based on the Provided 510(k) Clearance Letter:
The Forcyte Autograft Harvest Kit (K243407) is a physical medical device, not an AI/ML-enabled device or software medical device. The 510(k) clearance for this device was based on non-clinical (bench) testing and substantial equivalence to a predicate device, not on clinical performance studies involving human readers or AI algorithms.
Therefore, most of the requested information regarding AI acceptance criteria, clinical study design (sample size, expert ground truth, MRMC), and training data is not applicable to this specific device and the provided document.
Here's an attempt to address each point based on the provided text, clarifying what information is present and what is absent:
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria and performance data are related to the physical characteristics and functionality of the harvesting kit, not diagnostic accuracy.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Performance Metric (Type of Test) | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Simulated Use Testing | Satisfactory Operation | All testing had satisfactory results. |
| Tensile Testing | Within Engineering Specifications | All testing had satisfactory results. |
| Compression Testing | Within Engineering Specifications | All testing had satisfactory results. |
| Torque Testing | Within Engineering Specifications | All testing had satisfactory results. |
| Flexural Testing | Within Engineering Specifications | All testing had satisfactory results. |
| Vacuum Testing | Achieve/Maintain Required Vacuum | All testing had satisfactory results. |
| Biocompatibility | Meet ISO 10993 Standards | Indicating safety and effectiveness. |
| Sterilization/Shelf Life | Maintain Sterility & Integrity | All testing had satisfactory results. |
Note: The document states "All testing had satisfactory results" but does not provide specific numerical acceptance criteria or detailed numerical results for each test. The acceptance criteria are implicitly that the device performs as intended and meets safety requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of number of units or test runs for the bench tests. The document only states "bench testing including simulated use testing, tensile, compression, torque, flexural, and vacuum testing were conducted."
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. As these are bench tests, the concept of "retrospective" or "prospective" data collection from patients is not applicable. The tests would have been performed in a laboratory setting. No geographical origin of the testing data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a biopsy instrument, not an imaging or diagnostic AI device requiring expert interpretation for ground truth establishment. Bench testing does not typically involve "experts" establishing a "ground truth" in the diagnostic sense; rather, it involves engineers and quality control personnel assessing physical performance against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no expert interpretation or diagnostic "ground truth" was established, there was no need for an adjudication method. Bench testing results are typically assessed against pre-defined engineering and material 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
- No. The document explicitly states: "No clinical evaluations were conducted." Therefore, no MRMC study, human reader improvement, or AI assistance was involved in the clearance. This type of study is irrelevant for a physical bone harvesting instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or software. There is no "standalone" algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the diagnostic sense. For a physical device, "ground truth" is established by manufacturing specifications, engineering design, and material properties. The device's performance is measured against these established physical and functional parameters (e.g., tensile strength, proper vacuum seal, successful harvesting of material, biocompatibility).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 29, 2025
Forcyte Medical LLC
℅ Cheryl Wagoner
Consultant
Wagoner Consulting LLC
5215 Crosswinds Drive
Wilmington, North Carolina 28409
Re: K243407
Trade/Device Name: Forcyte Autograft Harvest Kit
Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-Urology Biopsy Instrument
Regulatory Class: Class II
Product Code: KNW
Dated: May 29, 2025
Received: May 29, 2025
Dear Cheryl Wagoner:
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 (the 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 available 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.
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K243407 - Cheryl Wagoner Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243407 - Cheryl Wagoner Page 3
assistance/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,
JESSE MUIR -S
Digitally signed by JESSE MUIR -S
Date: 2025.07.29 09:48:29 -04'00'
Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative, Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243407
Device Name: Forcyte Autograft Harvest Kit
Indications for Use (Describe):
FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
510(k) Summary
510(k) #: K243407
Prepared on: 2025-07-28
Contact Details 21 CFR 807.92(a)(1)
Applicant Name: Forcyte Medical LLC
Applicant Address: 2275 Northwest Parkway SE, Suite 160 Marietta GA 30067 United States
Applicant Contact Telephone: 612-860-1232
Applicant Contact: Mr. Robert Assell
Applicant Contact Email: rassell@forcytemed.com
Correspondent Name: Wagoner Consulting LLC
Correspondent Address: 5215 Crosswinds Drive Wilmington NC 28409 United States
Correspondent Contact Telephone: 910-386-9019
Correspondent Contact: Ms. Cheryl Wagoner
Correspondent Contact Email: cheryl@wagonerconsultingllc.com
Device Name 21 CFR 807.92(a)(2)
Device Trade Name: Forcyte Autograft Harvest Kit
Common Name: Gastroenterology-urology biopsy instrument
Classification Name: Instrument, Biopsy
Regulation Number: 876.1075
Product Code(s): KNW
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K210631 | Avitus Precision Autograft Delivery | KNW |
Device Description Summary 21 CFR 807.92(a)(4)
The Subject device is a kit comprised of a bone and marrow harvesting needle, collection jar, suction tubing, drill-tip guide pin, and bone void filler hydration chamber. The FORCYTE system harvests autologous bone and marrow for use as a bone void filler.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.
Indications for Use Comparison 21 CFR 807.92(a)(5)
Page 6
The Subject device and its predicate have similar technology. The intended use are the same with some wording differences.
Technological Comparison 21 CFR 807.92(a)(6)
The Subject and predicate devices have similar technological characteristics as manual autograft harvesting instrumentation.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
There are not specific test standards that are applicable for performance testing of this device. However, bench testing including simulated use testing, tensile, compression, torque, flexural, and vacuum testing were conducted. No clinical evaluations were conducted. Sterilization/shelf life testing were conducted. All testing had satisfactory results.
The biocompatibility, sterilization, and bench testing all indicate that the Subject device is safe, effective and performs as intended and as well as its predicate.
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Forcyte Autograft Harvest Kit Page 3 of 3
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).