(126 days)
Not Found
Unknown
The device description mentions "personalized aprevo™ devices incorporate patient specific features" and that "The individualized surgical correction plan and device configurations are developed using patient CT scans." While this suggests some level of computational analysis of CT data to create personalized devices, the summary does not explicitly state that AI or ML algorithms are used in this process. It could be based on traditional image processing and geometric modeling techniques. The lack of mention of AI/ML in the dedicated section and the absence of details about training/test sets further support the "Unknown" determination.
Yes
The device is intended for interbody fusion in the lumbar spine, which is a therapeutic intervention to treat conditions like severe symptomatic adult spinal deformity.
No
The device is an interbody device intended for interbody fusion in the lumbar spine, specifically designed to stabilize the spinal column and facilitate fusion. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the aprevo™ devices are manufactured from Titanium Alloy and have a cavity for bone graft, indicating a physical implant, not software only.
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 provided text clearly describes a surgical implant (an interbody fusion device) used to stabilize the lumbar spine and facilitate bone fusion. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is mechanical support and facilitating bone growth in vivo.
The device uses patient CT scans for planning and personalization, but this is for surgical planning and device design, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The aprevo™ Transforaminal interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ Personalized Interbody device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The aprevo™ Transforaminal IBF, including the aprevo™ transforaminal curved lumbar interbody fusion (TLIF-C) and the aprevo™ transforaminal oblique lumbar interbody fusion (TLIF-O), are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo™ devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001. The aprevo™ TLIF-C and aprevo™ TLIF-O devices have a cavity intended for the packing of bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
lumbar spine
Indicated Patient Age Range
skeletally mature patients
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)
The aprevo™ Transforaminal IBF has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
- TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy
The results of this non-clinical testing show that the mechanical performance of the aprevo™ Transforaminal IBF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2021
Carlsmed, Inc. Karen Liu VP Quality and Regulatory 4250 Executive Sq., Ste. 675 La Jolla, California 92037
Re: K210542
Trade/Device Name: aprevo™ Transforaminal IBF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 29, 2021 Received: June 30, 2021
Dear Karen Liu:
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
1
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 (OS) 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 L. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
| 510(k) Number (if known) | K210542 |
|---|---|
| Device Name | aprevo™ Transforaminal IBF |
Indications for Use (Describe)
The aprevo™ Transforaminal interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ Personalized Interbody device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.
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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displavs a currently valid OMB number. '
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(K) SUMMARY
| Submitter's Name: | Carlsmed, Inc. |
|---|---|
| Submitter's Address: | 4250 Executive Sq., Ste. 675 |
| La Jolla, CA 92037 | |
| Submitter's Telephone: | 760-766-1926 |
| Contact Person: | Karen Liu, VP Quality and Regulatory |
| Carlsmed, Inc. | |
| 760-766-1926 | |
| regulatory@carlsmed.com | |
| Date Summary was Prepared: | 29-Jun-2021 |
| Trade or Proprietary Name: | aprevo™ Transforaminal IBF |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The aprevo™ Transforaminal IBF, including the aprevo™ transforaminal curved lumbar interbody fusion (TLIF-C) and the aprevo™ transforaminal oblique lumbar interbody fusion (TLIF-O), are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo™ devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001. The aprevo™ TLIF-C and aprevo™ TLIF-O devices have a cavity intended for the packing of bone graft.
INDICATIONS FOR USE
The aprevo™ Transforaminal interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ Personalized Interbody device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.
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K210542 Page 2 of 2
TECHNOLOGICAL CHARACTERISTICS
The aprevo™ Transforaminal IBF is made from titanium alloy that conforms to ASTM F3001. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for use ●
- Technological characteristics
- . Sizes
- Materials of manufacture .
- Patient specific adaptable features .
- Mechanical functionality ●
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate Type |
|----------------|-----------------------------------------------|---------------------------|----------------|
| K190092 | UNiD Patient-specific 3D
printed TLIF cage | Medicrea
International | Primary |
| K182158 | UNiD Patient-matched PLIF
cage | Medicrea
International | Additional |
| K202034 | aprevo™ Intervertebral Body
Fusion Device | Carlsmed, Inc. | Additional |
PERFORMANCE DATA
The aprevo™ Transforaminal IBF has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077
- . Dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267 .
- . TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy
The results of this non-clinical testing show that the mechanical performance of the aprevo™ Transforaminal IBF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall indications for use, technology characteristics, and mechanical performance data lead to the conclusion that the aprevo™ Transforaminal IBF is substantially equivalent to the predicate device.