(96 days)
Not Found
No
The device description focuses on a physical, bioresorbable mesh pouch for bone void filling and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is intended to fill voids and gaps in the skeletal system, act as a bone void filler and bone graft extender, and is implanted into the body, which aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
This device is described as a "Resorbable Mesh Pouch" intended to "fill voids and gaps in the skeletal system" as a "bone void filler and bone graft extender." Its function is structural and reparative, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, implantable medical device made of bioresorbable material and accessories, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill voids and gaps in the skeletal system with autograft. This is a therapeutic and structural function within the body.
- Device Description: The device is an implantable pouch filled with autograft and surgically placed.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for in vitro (outside the body) examination of specimens to provide diagnostic information. This device is an implantable medical device used for bone repair.
N/A
Intended Use / Indications for Use
The Resorbable Mesh Pouch, once filled with autograft, is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.
Product codes
MQV
Device Description
The Resorbable Mesh Pouch is comprised of an empty bioresorbable poly(lactic-co-glycolic) acid (PLGA) pouch (open at one end and sealed at the other) and disposable polypropylene accessories. Utilizing the provided accessories, the Resorbable Mesh Pouch is to be filled with autograft by the clinician at the time of the procedure. Once filled, the Resorbable Mesh Pouch is to be closed using 2-0 Vicry1® sutures available to the clinician in the Operating Room (not provided with the finished device). The filled, closed device is intended to be implanted into the posterolateral spine and pelvis.
The Resorbable Mesh Pouch is provided in individually sterile packaged units. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterolateral spine and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician / Operating Room
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
Non-Clinical Testing:
An in vivo (animal) study for safety and performance was conducted and demonstrated comparable resorption, remodeling and rates of fusion when compared to an autograft control. The study employed various analyses and endpoints were assessed at several time points. A sterilization validation was performed and complies with ISO 11137, Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 10-9.
Clinical Testing:
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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SeaSpine Orthopedics Corporation Caryn Sailor Manager, Regulatory Affairs 2 Goodyear Irvine, California 92618
Re: K200290
Trade/Device Name: Resorbable Mesh Pouch (Ballast® MT, OsteoBallast® MT) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: April 8, 2020 Received: April 9, 2020
Dear Ms. Sailor:
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 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
May 11, 2020
1
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.
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200290
Device Name
Resorbable Mesh Pouch (Trade names: Ballast MT, OsteoBallast MT)
Indications for Use (Describe)
The Resorbable Mesh Pouch, once filled with autograft, is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.
| 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 | K200290 | |
|---|---|---|
| Contact Details | ||
| Owner Operator Name: | SeaSpine Orthopedics Corporation | |
| Address: | 5770 Armada Drive, Carlsbad CA | |
| Establishment Name: | IsoTis OrthoBiologics, Inc. | |
| Address: | 2 Goodyear, Irvine, CA | |
| Phone number: | (949) 855-7174 | |
| Fax number: | (949) 595-8711 | |
| Contact person: | Caryn Sailor, Manager, Regulatory Affairs | |
| Email address: | caryn.sailor@seaspine.com | |
| Date Prepared: | May 11, 2020 | |
| Device Name | ||
| Trade Name: | Resorbable Mesh Pouch (Ballast® MT, OsteoBallast® MT) | |
| Common Name: | Bone Void Filler | |
| Classification: | 21 CFR 888.3045 | |
| Classification Name: | Resorbable Bone Void Filler | |
| Class: | II | |
| Product Code: | MQV |
Legally Marketed Predicate Device
Predicate – Resorbable Mesh Device
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K172130 | MQV | Resorbable Mesh | |
| Device | |||
| (Ballast, OsteoBallast) | IsoTis OrthoBiologics, Inc. |
Device Description
The Resorbable Mesh Pouch is comprised of an empty bioresorbable poly(lactic-co-glycolic) acid (PLGA) pouch (open at one end and sealed at the other) and disposable polypropylene accessories. Utilizing the provided accessories, the Resorbable Mesh Pouch is to be filled with autograft by the clinician at the time of the procedure. Once filled, the Resorbable Mesh Pouch is to be closed using 2-0 Vicry1® sutures available to the clinician in the Operating Room (not provided with the
4
finished device). The filled, closed device is intended to be implanted into the posterolateral spine and pelvis.
The Resorbable Mesh Pouch is provided in individually sterile packaged units. The product is terminally sterilized by electron beam irradiation and validated to ensure a minimum Sterility Assurance Level (SAL) of 10-6.
Intended Use/Indications for use
The Resorbable Mesh Pouch, once filled with autograft, is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use in the posterolateral spine and pelvis as a bone void filler and bone graft extender. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Ultimately, the Resorbable Mesh Pouch will be resorbed.
Summary of Technological Characteristics
The Resorbable Mesh Pouch is similar to the cited predicate device in regard to components, device description, intended use/indications for use, device characteristics (design, materials, sterility, manufacturing, etc.) and performance.
Summary of Non-Clinical Testing to Support Substantial Equivalence
The subject device is the same as the predicate device in terms of materials and manufacturing process of the PLGA mesh pouch. The subject device does not introduce a new worst case for biocompatibility and bacterial endotoxin. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing and USP Bacterial Endotoxin Test and has been validated ensure a BET limit of ≤20 EU/Device. An in vivo (animal) study for safety and performance was conducted and demonstrated comparable resorption, remodeling and rates of fusion when compared to an autograft control. The study employed various analyses and endpoints were assessed at several time points. A sterilization validation was performed and complies with ISO 11137, Sterilization of Health Care Products – Radiation to ensure a sterility assurance level (SAL) of 10-9.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the Resorbable Mesh Pouch is substantially equivalent to the cited legally marketed predicate.