(222 days)
No
The device description focuses on the material composition and physical properties of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to fill bony voids and gaps and is replaced by bone during the healing process, thereby aiding in the repair and recovery of skeletal structures.
No
Explanation: The device is described as an implant intended to fill bony voids or gaps in the skeletal system, which functions as a bone graft substitute, and is not used for diagnosis.
No
The device description clearly describes a physical implant made of ceramic granules and a polymer carrier gel, intended to fill bony voids. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that si-Mochi is an implant intended to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description details a ceramic granule and gel material designed for implantation and bone regeneration. It describes its physical properties and how it interacts with the body's healing process.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used outside the body to analyze samples (like blood, urine, tissue) to provide diagnostic information. si-Mochi is an implantable device used within the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, pelvis). These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. si-Mochi resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
si-Mochi contains a multi porous bi-phase Calaium Phosphate ceramic granules, 12mm, suspended in an aqueous polymer carrier gel. The chemical composition of the multi-porous ceramic granules is trace silicate induced bi-phase calcium phosphate ceramic which has 80% hydroxylapatite Ca5(PO4)3(OH) and 20% beta -tricalcium phosphate Ca3(PO4)2 , similar levels to those identified in naturally-growing bone.1mm), midipores (10
Its porous structure comprising three types of porosities which are interconnected: macropores (100µm100 µm) and microspaces (110 µm).
Calcium phosphate bone graft substitutes have been the topic of extensive clinical studies for several decades. Biocompatibility is addressed in the non-clinical testing section below. The interconnected macro-, midi- and micro- porous structure encourages the rapid formation of host bone and the growth of capillary blood vessels throughout the network of interconnecting pores. After implantation, si-Mochi undergoes physiologically-mediated resorption and is replaced by natural bone.
The resorption of the Ca/P porous ceramic granules were controlled by the host nature bone remodelling process due to the proliferated osteocytes formation within the microporous structure of the ceramic granules. The resorption is not controlled by its chemical composition. si-Mochi is supplied in three different types of sterile applicator. si-Mochi does not set in-situ following implantation. si-Mochi does not contain antibiotics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, pelvis)
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)
Animal study, rabbit critical size defect in the distal femora model, making direct comparison against the predicate device, Actifuse ABX. However, the percentage of new bone formations were not statistically significant difference in animal model at all time points post-implantation between si-Mochi and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TriPore® K070132, Actifuse ABX™ K082575
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.
0
April 21, 2021
Image /page/0/Picture/1 description: The image contains 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.
Biostone Limited Wei-Jen Lo, Ph.D. Chief Scientific Officer BioCity, Pennyfoot Street Nottingham, Notts NG1 1GF United Kingdom
Re: K202639
Trade/Device Name: si-Mochi Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: March 16, 2021 Received: March 29, 2021
Dear Dr. Lo:
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
1
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,
for
Laura C. Rose, 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K202639
Device Name
si-Mochi
Indications for Use (Describe)
si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, pelvis). These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. si-Mochi resorbs and is replaced with bone during the healing process.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| Submitter
Telephone
Facsimile
Contact Person | Biostone Limited
BioCity
Pennyfoot Street
Nottingham
NG1 1GF
United Kingdom
011 44 7906 001281
Wei-Jen Lo PhD |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared
Trade Name | 21/ July/ 2019
si-Mochi |
| Common Name | Resorbable calcium salt bone void filler device |
| Classification | Resorbable calcium salt bone void filler devices have
been classified by the Orthopedics Device Panel as
Class II Special Controls per 21 CFR 888.3045.
Product code: MQV |
| Predicate Devices | TriPore® K070132, Actifuse ABX™ K082575 |
| Device Description | si-Mochi contains a multi porous bi-phase Calaium
Phosphate ceramic granules, 12mm, suspended in an1mm),
aqueous polymer carrier gel. The chemical composition of
the multi-porous ceramic granules is trace silicate induced
bi-phase calcium phosphate ceramic which has 80%
hydroxylapatite $Ca_5(PO_4)_3(OH)$ and 20% $β$ -tricalcium
phosphate $Ca_3(PO_4)_2$ , similar levels to those identified in
naturally-growing bone.
Its porous structure comprising three types of porosities
which are interconnected: macropores (100µm
midipores (10100 µm) and microspaces (110 µm).
Calcium phosphate bone graft substitutes have been
the topic of extensive clinical studies for several decades.
Biocompatibility is addressed in the non-clinical testing
section below. The interconnected macro-, midi- and
micro- porous structure encourages the rapid formation of
host bone and the growth of capillary blood vessels
throughout the network of interconnecting pores. After
implantation, si-Mochi undergoes physiologically-
mediated resorption and is replaced by natural bone. |
| | The resorption of the Ca/P porous ceramic granules
were controlled by the host nature bone remodelling
process due to the proliferated osteocytes formation
within the microporous structure of the ceramic
granules. The resorption is not controlled by its chemical
composition. si-Mochi is supplied in three different types
of sterile applicator. si-Mochi does not set in-situ
following implantation. si-Mochi does not contain
antibiotics. |
| Intended Use | si-Mochi is an implant intended to fill bony voids or
gaps of the skeletal system (i.e. extremities, pelvis).
These osseous defects may be surgically created or
the result of traumatic injury to the bone and are not
intrinsic to the stability of the bony structure. si-Mochi
resorbs and is replaced with bone during the healing
process. |
| Technical Characteristics
and Substantial
Equivalence | si-Mochi and the predicate device, Actifuse ABX share
similar characteristics in that they are all calcium salt
bone void fillers covered by 'Class II Special Controls
Guidance Document: Resorbable Calcium Salt Bone
Void Filler Device" (FDA Guidance Document 855,
dated June 2, 2003).
Both si-Mochi and Actifuse ABX are packed in different
type of applicator for different clinic application. Both
have the multi-porous Ca/P ceramic granules with
added trace silicate, 1~2mm, suspended in the same
chemical composition of synthetic aqueous binding gel.
The multi-porous ceramic granules in si-Mochi are near
identical to TriPore SBG. They share the same chemical
composition but the multiparous Ca/P ceramic granules
had added additional trace silicate. They have the same
multi-porous structure and their manufacturing process
and annealing profile are exactly the same. |
| Determination of
substantial equivalence | Biostone has determined that si-Mochi is substantially
equivalent to the predicate devices on the basis of |
| (non-clinical data) | chemical composition tests on all three devices as prescribed in the
'Class II Special Controls Guidance Document' referenced above.
Secondly, si-Mochi itself complies with the requirements of the Special
Controls Document referred to above. The non-clinical data also included
biocompatibility, pyrogenicity testing and endotoxin monitoring, shelf-life a
packaging validation. |
| Determination of
substantial
equivalence
(animal studies) | Animal study, rabbit critical size defect in the distal femora model,
making direct comparison against the predicate device, Actifuse ABX.
However, the percentage of new bone formations were not statistically
significant difference in animal model at all time points post-implantation
between si-Mochi and the predicate device. |
| Technical
Characteristics
Difference | si-Mochi and Actifuse ABX
- The first is the chemical composition, where the calcium phosphate
granules in Actifuse ABX is pure hydroxylapatite with 0.8% Silicate. T
calcium phosphate granules in si-Mochi comes as bi-phase calcium
phosphate comprised of 20% beta tri-calcium phosphate and 80%
hydroxylapatite with 0.8% silicate. The differences in the chemical
composition of the porous calcium phosphate ceramic granules do not
affect the safety or effectiveness of si-Mochi, since all materials are
resorbable and provide the same function. - The second is the viscosity of the Kolliphor gel in both si-Mochi and
Actifuse ABX. The composition of Kolliphor gel in the Actifuse ABX is a
20%, and the viscosity will increase when the temperature raised to
human body temperature at 37°C. However, it was found that the low
viscosity gel is not sufficient to hold the granules together during the
lower operation theater temperature. Therefore, the composition of the
Kolliphor gel was increased to 33% to construct si-Mochi, for si-Mochi
function normally in operation theater condition. The Kolliphor gel is
bioinert and will not impede the function of the porous calcium
phosphate ceramic granules as the bone ingrowth scaffold.
si-Mochi and Tripore
The only difference is that the porous Ca/P ceramic granules contain
additional 0.8% of Silica in its chemical composition, the same as the othe
predicate device Actifuse ABX. However, the added Silica shall not affect
clinical performance. Since the osteointegration thesis of the porous cerar
granules and TriPore® are precisely the same.
These differences do not raise new issues of safety. |
| Conclusions | Therefore, Biostone concludes that the non clinical and animal studios |
4
5
| Conclusions | Therefore, Biostone concludes that the non-clinical and animal studies
discussed above demonstrate that si-Mochi performs as well the predicate
device. |
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