(395 days)
Not Found
Not Found
No
The document describes a physical implant and its deployment system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is marketed for the treatment of massive, irreparable full-thickness torn rotator cuff tendons, which is a therapeutic indication. It is designed to reduce pain and restore function to the gleno-humeral joint.
No
The InSpace™ Subacromial Tissue Spacer System is a device designed for treatment (surgical implantation) of torn rotator cuff tendons, not for diagnosis.
No
The device description clearly states it is comprised of a biodegradable implant and a deployer, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The InSpace™ Subacromial Tissue Spacer System is a physical implant designed to be surgically placed in the subacromial space of the shoulder. It is a biodegradable material that acts as a spacer.
- Intended Use: The intended use is for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive. irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
QPQ
Device Description
The InSpace™ Subacromial Tissue Spacer System (Figure 1) is a prescription-use device that is comprised of a biodegradable implant provided pre-loaded on a deployer. The deployer is designed for deployment, inflation, sealing, and detachment of the implant in the subacromial space between the humeral head and the acromion. The system is single-use, supplied sterile, and ready for use in the operating room upon removal from the package. Once positioned in the subacromial space, the implant is filled with sterile saline (0.9%, not provided) to the pre-defined volume, sealed, and released from the deployer. Following implantation, it is designed to biodegrade over approximately one year.
The implant is supplied pre-folded within the cylindrical protective tube of the deployer to facilitate insertion into the subacromial space and achieves its final shape by subsequent unfolding via inflation with sterile saling, and detachment. It is supplied in three sizes to accommodate individual anatomical variations (Small, Medium, or Large). The InSpace implant is designed to reduce pain and restore function to the gleno-humeral joint by acting as a temporary spacer between the humeral head and acromion, enabling smooth gliding between the bones and reducing acromio-humeral contact pressure while depressing the humeral head to a more central anatomical position on the glenoid, similar to that of a shoulder with an intact rotator cuff.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging (MRI)
Anatomical Site
Shoulder, subacromial space
Indicated Patient Age Range
greater than or equal to 65 years of age
Intended User / Care Setting
Prescription use, surgical setting (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical/Bench Studies:
- Biocompatibility: The implant is made from Poly L-Lactide-co-ε-caprolactone (Resomer® LC 703). Biocompatibility evaluation was completed per FDA Guidance, Use of International Standard ISO 10993-1. Cytotoxicity, intracutaneous irritation, systemic sub-acute and chronic toxicity, sensitization, material mediated pyrogenicity testing, chemical characterization, and toxicological risk assessment were conducted. The device was determined to be biocompatible.
- Sterility/Packaging/Shelf Life/Pyrogenicity:
- Sterility: Sterilized by ethylene oxide in accordance with ISO 11135:2008 to a sterility assurance level (SAL) of 10-6.
- Packaging: Three layers (blister, foil, carton) with validation per ISO 11607-1:2006 and ISO 11607-2:2006.
- Shelf Life: Tested with 1-year real-time, 3-year accelerated, and 3-year real-time aged samples. Devices passed functionality testing; material and packaging properties did not degrade significantly.
- Pyrogenicity: Met specifications of 40 years old; positive MRI diagnosis of massive irreparable full-thickness rotator cuff tear (MRCT) that could not be fully repaired surgically; baseline VAS pain score > 30 mm; baseline WORC total score ≥420.
- Control Group: Partial repair of a full-thickness MRCT (standard of care).
- Follow-up: 24 months.
- Primary Effectiveness Endpoints (at 24 months):
- WORC improvement of ≥275 points from pre-operative baseline.
- ASES improvement of >6.4 points from pre-operative baseline.
- No subsequent secondary surgical interventions (SSSI) in the index shoulder through post-surgery.
- Absence of Serious Adverse Device Effects (SADEs) through post-surgery.
- Key Results (Primary Endpoint - Month 24, Per-Protocol Population):
- All subjects: InSpace™ success rate 86.6% (71/82), Partial Repair 91.1% (72/79). P-value = 0.06 (non-inferiority not statistically achieved for all subjects).
- Subjects
§ 888.3630 Resorbable shoulder spacer.
(a)
Identification. A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Evaluation of improvement of shoulder function and reduction of symptoms (
e.g., pain and function) for the indications for use; and(ii) Evaluation of relevant adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Integrity testing of the device, including mechanical and chemical stability; and
(ii) Characterization of the device degradation profile.
(3) Animal performance testing must include evaluation of the following:
(i) Adverse effects, including gross necropsy and histopathology; and
(ii) Device degradation to verify in vitro versus in vivo degradation correlation.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Instruction for use, including specific instructions regarding device selection and placement;
(ii) A detailed summary of the clinical performance testing with the device, including procedure- and device-related complications or adverse events; and
(iii) A shelf life.
0
DE NOVO CLASSIFICATION REQUEST FOR INSPACE™ SUBACROMIAL TISSUE SPACER SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Resorbable shoulder spacer. A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
NEW REGULATION NUMBER: 21 CFR 888.3630
CLASSIFICATION: Class II
PRODUCT CODE: QPQ
BACKGROUND
DEVICE NAME: InSpace™ Subacromial Tissue Spacer System
SUBMISSION NUMBER: DEN200039
DATE DE NOVO RECEIVED: June 12, 2020
SPONSOR INFORMATION:
Ortho-Space Ltd. 7 Halamish Street Caesarea, 3079579 Israel
INDICATIONS FOR USE
The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive. irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
LIMITATIONS
The sale, distribution, and use of the InSpace Subacromial Tissue Spacer System are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
The InSpace™ Subacromial Tissue Spacer System (Figure 1) is a prescription-use device that is comprised of a biodegradable implant provided pre-loaded on a deployer. The deployer is designed for deployment, inflation, sealing, and detachment of the implant in the subacromial space between the humeral head and the acromion. The system is single-use, supplied sterile, and ready for use in the operating room upon removal from the package. Once positioned in the subacromial space, the implant is filled with sterile saline (0.9%, not provided) to the pre-defined volume, sealed, and released from the deployer. Following implantation, it is designed to biodegrade over approximately one year.
Image /page/1/Figure/2 description: The image shows a medical device with the label "Deployer" pointing to the main body of the device. The device has a white handle with green accents, a red trigger mechanism, and a long white tube extending from the handle. The label "Implant" points to a small, metallic component at the end of the tube, near a blue, shell-shaped object.
Figure 1: InSpace System Components, including the Deployer and Implant (in both folded and unfolded states)
The implant is supplied pre-folded within the cylindrical protective tube of the deployer to facilitate insertion into the subacromial space and achieves its final shape by subsequent unfolding via inflation with sterile saling, and detachment. It is supplied in three sizes to accommodate individual anatomical variations (Small, Medium, or Large). The InSpace implant is designed to reduce pain and restore function to the gleno-humeral joint by acting as a temporary spacer between the humeral head and acromion, enabling smooth gliding between the bones and reducing acromio-humeral contact pressure while depressing the humeral head to a more central anatomical position on the glenoid, similar to that of a shoulder with an intact rotator cuff.
2
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY
The InSpaceTM Subacromial Tissue Spacer System implant is manufactured from the following material shown in Table 1:
Table 2: InSpace Implant Material, Patient Contact Status, and Contact Duration
| Description | Material | Direct Patient
Contact | Contact Duration |
|-------------|-----------------------------------------------------------|---------------------------|-------------------|
| Implant | Poly L-Lactide-co-ε-
caprolactone (Resomer® LC
703) | Yes | Permanent (>30 d) |
Table 3: InSpace Implant Material, Patient Contact Status, and Contact Duration,
Biocompatibility evaluation of the implant and the deployer have been completed according to FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1; Evaluation and testing within a risk management. process. Cytotoxicity, intracutaneous irritation, systemic sub-acute and chronic toxicity, sensitization and material mediated pyrogenicity testing were conducted per ISO-10993-1. Chemical characterization and toxicological risk assessment were evaluated to address systemic toxicity, genotoxicity, and carcmogenicity endpoints for the implant. Exhaustive extraction along with characterization of the extract, did not show any extract in concentrations that would be of biocompatibility concern. Based on all the biocompatibility testing and evaluations, the InSpace Subacromial Tissue Spacer System was determined to be biocompatible.
STERILITY/PACKAGING/SHELF LIFE/PYROGENICITY
Sterility:
The subject device is provided sterile to the end user. The device is sterilized by ethylene oxide in accordance with ISO 11135:2008 "Sterilization of health care products -Ethylene oxide: Requirements for development, qualification, and routine control of a sterilization process for medical devices" to a sterility assurance level (SAL) of. 10-6.
Packaging:
Packaging for the subject device is composed of three layers: the sterile barrier system (blister pack), moisture barrier system (foil pack), and final packaging system (single unit. carton pack with IFUs). Packaging validation testing included visual inspection, peel strength testing, dye penetration testing, bubble emission testing, and simulated distribution testing in accordance with ISO 11607-1:2006 and ISO 11607-2:2006.
Shelf Life:
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Representative sterilized samples real-time aged to 3 years were used to determine the shelf life of the device. Functionality testing was conducted to verify that the devices still functioned as expected after: 1-year real-time aged samples, 3-year accelerated aged samples, and 3-year real-time aged samples. The material and packaging properties did not degrade significantly during accelerated or real-time aging, and the devices passed the functionality testing after aging.
Pyrogenicity:
In accordance with the FDA Guidance Document. "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016) and the recommendations and limits specified in United States Pharmacopeia 38, National Formulary 33, General Chapter , devices that are intended to be implantable should meet pyrogen limit specifications of In vitro degradation | To study the
degradation
mechanism and
profile of the
implant | Physiochemical
test | Characterized the degradation of the
implant over time via hydrolysis. At
(b) (4) week (b) (4)(final time point), the
implant was mostly degraded. |
| In vitro versus in
vivo degradation | To correlate
between in vitro
and in vivo
degradation | Physiochemical
test | Demonstrated in vitro-in vivo
correlation in terms of molecular
weight and viscosity. The
acceptance criteria were met in each
case ((b) (4) degradation after (b) (4)
(b) (4)weeks). |
| Fatigue testing of
inflated implants | To demonstrate the
ability of the device
to withstand fatigue
cycles under
simulated condition | Mechanical test | Results showed average weight loss
after (b) (4) days of periodical cyclic
testing was (b) (4)
considering standard deviation
which met the acceptance criterion
of less than (b) (4) weight loss.
Additionally, there were no signs of
degradation or failure observed
during visual inspection. |
| Resistance to
external loads | To demonstrate
resistance of the
device to loads
simulating extreme
physiological forces
in the shoulder | Mechanical test | The acceptance criteria required that
the implants could sustain a load
greater than or equal to (b) (4)
(b) (4) representing two times the
maximum force expected on the
implant in the subacromial space
during the early post-operative
period. Results showed that the
average maximum load at failure
was(b) (4) range: (b) (4)
(b) (4) thus meeting the
acceptance criteria. Furthermore,
statistical analysis of the data
showed that with (b) (4) reliability, the
implants could withstand loads |
| | | greater than (b) (4)(safety factor of
(b) (4) | |
Table 2: Physicochemical and mechanical tests conducted for the subject device.
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PERFORMANCE TESTING - ANIMAL
The objective of the pilot animal study was to assess biocompatibility, device degradation and safety of the subject device following implantation in the shoulder joint of (b) (4)A Good Laboratory Practices (GLP) study was performed in this model (n=30) to assess the biocompatibility of the subject device in the "shoulder at (b) (4) and " " - weeks posttreatment, and of healing through histopathologic examination as well as determination of hematology and biochemistry parameters. The observed long-term tissue and cellular response to the implant material in the " shoulder was within accepted parameters for a foreign body reaction to a biodegradable material, and the changes were indicative of excellent tolerance of the device. Another GLP study in (4)(n=15) was performed to assess biodegradability of the subject device following subcutaneous implantation at (6) (4) (b) (4) and "" -weeks post-treatment. The results demonstrated similar degradation rates between in vitro and in vivo datasets based on molecular weight and inherent viscosity, meeting the pre-specified acceptance criteria. While these studies support biocompatibility of the device material, the animal performance testing is inadequate to assess the effectiveness of the device for its intended use. There is not a validated animal model to assess the effectiveness of this device primarily due to differences in biomechanics between quadrupeds and bipeds. As such, the utility of the animal model is limited to testing biocompatibility parameters.
SUMMARY OF CLINICAL INFORMATION
Study Design
A pivotal clinical trial was conducted with a non-inferiority, prospective, single blinded, multicenter, randomized, controlled study design at 22 sites (19 sites in the US and 3 sites in Canada). The study enrolled 184 subjects (93 investigational: 91 control) who were > 40 years old with: positive diagnosis upon magnetic resonance imaging (MRI) of a full-thickness massive rotator cuff tear (MRCT) that could not be fully repaired surgically; baseline visual analog score (VAS) pain score > 30 mm; and, baseline Western Ontario Rotator Cuff index (WORC) total score ≥420. The purpose of the study was to evaluate the safety and effectiveness of the device as a primary surgical treatment for a MRCT compared to partial repair of a full-thickness MRCT performed during an arthroscopic procedure. Subjects were subsequently followed out to Month 24 post-treatment for the end of study analysis.
Subject Demographics
A total of 184 subjects were enrolled and randomized. The study included an active, standard of care control treatment group (Partial Repair) and an investigational treatment group (InSpace™). The two treatment groups were similar in terms of demographics and baseline characteristics, with an overall mean age of approximately 66 years (range: 44 to 84 years). The study population was 55% male with average body mass index ("BMI") of 30. On average, subjects
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began experiencing symptoms 33.5 months prior to enrollment. The most common reported causes of the MRCT, in both treatment groups, were tendon degeneration associated with age, low energy fall, other, and fall from height. The racial composition of the study was 88% white, 8% black/African American, 1% Asian, and 3% other. Most subjects were not Hispanic or Latino (98%).
Primary Effectiveness Endpoints
The Primary Composite Endpoint for the study was defined as follows at 24 months:
. Western Ontario Rotator Cuff ("WORC") improvement of ≥275 points from pre-operative baseline;
. American Shoulder and Elbow Surgeons Standardized Shoulder Assessments ("ASES") improvement of >6.4 points from pre-operative baseline:
. No subsequent secondary surgical interventions ("SSSI") in the index shoulder through post-surgery; and
. Absence of Serious Adverse Device Effects ("SADEs"), through post-surgery.
The sponsor originally proposed pain and function assessments at Week 6 post-surgery and only those subjects identified as a success were considered for evaluation at Month 12 post-surgery (later revised to Month 24 post-surgery based upon FDA feedback). FDA requested that the Primary Composite Endpoint be assessed only at the Month 24 post-surgery visit due to differences in post-surgery rehabilitation and the resulting effect on outcomes at the Week 6 timepoint. The Per-Protocol (PP) analysis population is used for non-inferiority testing for the Primary Composite Endpoint. Results are presented in Table 3 for all study subjects at the Month 24 timepoint only (as requested by FDA), as well as in the subpopulations of subjects less than 65 years of age and 65 vears of age and older.
The Revised Primary Composite Endpoint was assessed when all subjects reached their Month 24 post-treatment visit. Results are presented in the table below for all study subjects, as well as in the subpopulations of subjects less than 65 years of age and 65 years of age and older. As shown below, Month 24 post-treatment success rates are above 77% for all presented subpopulation analyses of both the treatment groups in both the PP and intent-to-treat (ITT) analysis populations. While non-inferiority was not statistically achieved for the population containing all subjects (p=0.06), non-inferiority was established in the subgroup of subjects 65 years of age and older (p=0.01). Additionally, it is noted that the InSpace™ group success rate was 84.8%, compared to 94.6% for the Partial Repair group in the PP population for patients 65 years of age at 24 months post-treatment.
- 2) The clinical study demonstrated positive results in secondary endpoints that support longterm, clinically meaningful, patient valued benefits - in particular Range of Motion (ROM) and VAS pain - at a magnitude similar to, or numerically greater than, those observed with the control group (partial repair).
-
- The clinical study reported a shorter surgical time (25-30 minutes) and a less invasive surgery for the subject device as compared to the control group (partial repair).
RISKS:
-
- There is a 47% increased relative risk of total adverse events of the operative shoulder, with 95% certainty (Risk Ratio: 1.47; 95% CI 1.02, 2.10) when using the subject device compared to undergoing a partial rotator cuff repair in the arthroscopic treatment of full thickness, irreparable massive rotator cuff tears.
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-
- The InSpace™ subjects have a 44% increased relative risk for being treated with any medication (oral medications or injections) for an adverse event of the index shoulder as compared to the control (partial repair) subjects.
-
- The InSpace™ subjects have an increased relative risk for experiencing an adverse event that is associated with a serious risk of the index shoulder, which includes both medical (e.g., open opioid prescriptions at last follow-up or study conclusion) and surgical (e.g., reverse total shoulder arthroplasty) treatments as compared to the control (partial repair) subjects.
-
- Migration or collapse/rupture of the subject device has been identified with 6-week MRI data in 28% to 53% of cases according to the manufacturer and FDA independent musculoskeletal radiologic assessments, respectively.
Based on the totality of the evidence, the InSpace™ Subacromial Tissue Spacer System demonstrated a reasonable assurance of safety and effectiveness for the device for its intended use/indications for use and there is a low degree of uncertainty in this finding. In conclusion, the benefits of using the subject device for its intended use/indications for use outweigh the risks to health.
Patient Perspectives
Patient perspectives considered for the InSpace™ Subacromial Tissue Spacer System included:
The primary composite study endpoints included assessment of improvement in pain and function using patient reported metrics (i.e., ASES and WORC scores) at month 24. Additionally, pre-specified secondary effectiveness study endpoints included the following scales: WORC, ASES, including range of motion ("ROM"), Constant-Murley Shoulder Scale, VAS Pain Scale, and EQ-5D-5L to evaluate the treatment effect throughout the study. Of note, both the InSpace and partial repair group performed similarly on patient reported function and pain metrics (i.e., WORC, ASES, VAS pain). These patient reported outcomes are used to demonstrate a clinically meaningful improvement in pain and function.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
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The probable benefits outweigh the probable risks for the InSpace™ Subacromial Tissue Spacer Systems. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the InSpace™ Subacromial Tissue Spacer System is granted and the device is classified as follows:
Product Code: QPQ Device Type: Resorbable shoulder spacer Regulation Number: 21 CFR 888.3630 Class: II